WEEK ENDING NOVEMBER 5

PRODUCT Blood Bank Control Systems
CODE Software versions 4.0 and greater.
MANUFACTURER Blood Bank Computer Systems, Kent, Washington.
DISTRIBUTION California, Florida, Illinois, Kansas, Pennsylvania, Texas, Washington State.
QUANTITY 14 systems were distributed.
REASON Computer software contains programming errors that could potentially result in the release of a unit that has not been tested for antibodies.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #04R37916.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION New York and Maine.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of cancer.

PRODUCT a) Red Blood Cells; b) Source Leukocytes for Manufacture.
CODE Unit #0700265.
MANUFACTURER Bergen Community Regional Blood Center, Paramus, New Jersey.
DISTRIBUTION New Jersey and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported travel to an area designed as endemic for malaria.

PRODUCT Red Blood Cells
CODE Unit #49W24412.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had lived in an area designated as endemic for malaria.

PRODUCT Red Blood Cells
CODE Unit #42S66951.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled as leukoreduced but did not undergo leukoreduction.

PRODUCT Red Blood Cells
CODE Unit #3008296.
MANUFACTURER Wellmont Health System, doing business as Bristol Regional Medical Center, Bristol, Tennessee.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells
CODE Unit #29F28068.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported having lived in an area designated as endemic for malaria.

PRODUCT Platelets, Pheresis, Leukoreduced, Irradiated.
CODE Unit #16KF20408, part 2.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was incorrectly labeled as HLA matched.

PRODUCT a) Whole Blood; b) Red Blood Cells; c) Red Blood Cells, Deglycerolized; d) Platelets; e) Platelets, Pheresis; f) Fresh Frozen Plasma; g) Fresh Frozen Plasma, Pheresis; h) Cryoprecipitated AHF; i) Recovered Plasma.
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER New York Blood Services (Center West), New York, New York.
DISTRIBUTION New York, New Jersey, California, Switzerland.
QUANTITY a) 3 units; b) 36 units; c) 1 unit; d) 12 units; e) 2 units; f) 12 units; g) 4 units; h) 2 units; i) 23 units were distributed.
REASON Blood products may not have been tested in accordance with the manufacturer's instructions for either HCV or HbsAg.

PRODUCT a) Red Blood Cells, Irradiated; b) Platelets, Pheresis, Irradiated, Leukocytes Reduced
CODE Unit Numbers: a) X48625 and X51412; b) X46101.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Illinois.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products lacked documentation of irradiation.

PRODUCT Cryoprecipitated AHF
CODE Unit Numbers: 53KQ54716, 53KR41958, 53KR41963, 53V88521, 53KX35154, 53KX35155, 53KX35159, 53KX35160, 53KS38864, 53KS38867, 53Q73963.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland and District of Columbia.
QUANTITY 11 units were distributed.
REASON Blood products were incorrectly processed.

PRODUCT Red Blood Cells
CODE Unit Numbers: 29K17294, 53GM21762, 04W07543.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 3 units were distributed.
REASON Blood products had been stored at unsuitable temperatures.

PRODUCT Red Blood Cells
CODE 53FL72908, 53FL72921, 53GL98643, 53GL98646, 53M80764, 53J49805, 53L07668, 53GL98638.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 8 units were distributed.
REASON Blood products were shipped under unsuitable temperatures.

PRODUCT Source Plasma
CODE Units Numbers: 0460093369, 0460093796, 0460094429, 0460094577, 0460095257, 0460095360, 0460096091, 0460096327, 0460096919, 0460097084, 0460098070, 0460098680, 0460099083, 0460099657, 0460099910, 0460100486, 0460101017, 0460101449, 0460101679, 0460102098,
0460102503, 0460102803, 0460103346, 0460103641, 0460104012, 0460104305, 0460105080, 0460105538, 0460111501, 0460112096, 0460112276, 0460112893, 0460113524, 0460113786, 0460114539, 0460114876, 0460115382, 0460115748, 0460116210, 0460116502, 0460117042, 0460117285, 0460118020, 0460118258, 0460118723,0460119051, 0460119869, 0460120687, 0460121017, 0460121755, 0460122173, 0460122559, 0460123065, 0460123442, 0460124969, 0460125535, 0460125991, 0460126608, 0460127188, 0460127377, 0460128166, 0460128405, 0460129463, 0460129998, 0460130361, 0460131088, 0460131410, 0460133409, 0460135648, 0460136077, 0460136863, 0460137543, 0460138018, 0460138239, 0460139194, 0460140109, 0460140475, 0460141015, 0460141977, 0460142478, 0460143124, 0460144640, 0460145657, 0460146057, 0460147105, 0460147581, 0460148111, 0460148816, 0460149341, 0460149754, 0460152191, 0460153434, 0460153954, 0460155404, 0460156089, 0460089621, 0460090231, 0460090643, 0460091315, 0460091897, 0460092103, 0460092720, 0460092897, 0460106426, 0460106793, 0460107237, 0460107596, 0460108054, 0460108267, 0460109319, 0460109531, 0460110153, 0460110571, 0460110988, 0460069539,0460069764, 0460071017, 0460071435, 0460071905, 0460072558, 0460072881, 0460074373, 0460081025, 0460081246, 0460081810, 0460081946, 0460082592, 0460082710, 0460083411, 0460083519, 0460084499, 0460084706, 0460085245, 0460085661, 0460086577, 0460086727, 0460087820, 0460088008, 0460088567, 0460088809, 0460089267, 0460132235, 0460132597.
MANUFACTURER Nabi Biomedical Center, Dallas, Texas.
DISTRIBUTION New York, Korea, Germany, Switzerland.
QUANTITY 143 units were distributed.
REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested reactive for anti-HCV.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #479882.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had body piercing within 12 months of donation.

PRODUCT Source Plasma.
CODE Unit numbers: 09111608, 09111615, 09111622, 09111639, 09111646, 09111653, 09111660, 09111677, 09111684, 09111691, 09111707, 09111714.
MANUFACTURER Seramed, Inc., Tacoma, Washington.
DISTRIBUTION California.
QUANTITY 12 units were distributed.
REASON Blood products tested negative for all required viral marker tests, were distributed prior to testing.

PRODUCT Corneas
CODE Unit numbers: 20837 LC and 20837 RC.
MANUFACTURER Lions Eye Bank of Delaware Valley, c/o Willis Eye Hospital, Philadelphia, Pennsylvania.
RECALLED BY Lions Eye Bank of Delaware Valley, Philadelphia, Pennsylvania
DISTRIBUTION Florida and Texas.
QUANTITY 2 units were distributed.
REASON Corneas were collected from a donor who tested repeatedly reactive for the HIV p-24 antigen, and non-comfirmable by PCR.

PRODUCT Corneas
CODE Unit numbers: 99-1001 and 9-1002.
MANUFACTURER Georgia Eye Bank, Inc., Atlanta, Georgia.
DISTRIBUTION Georgia and Japan.
QUANTITY 2 units were distributed.
REASON Corneas were collected from a donor who tested repeatedly reactive for the HIV p-24 antigen, and non-confirmable by PCR.

PRODUCT Source Plasma
CODE 30GP08319, 30GP08329, 30GP08330, 30GP08358, 30GP08368, 30GP08376, 30GP08377.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
DISTRIBUTION California.
QUANTITY 7 units were distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #LW64240.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Sulfasalazine.

PRODUCT a) Red Blood Cells; b) Recovered Plasma; c) Red Blood Cells for Manufacturing Use; d) Platelets for Use in Manufacturing Non-Injectable Products.
CODE Unit Numbers: a) 259392; b) 259392, 273070 c) 273070; d) 275600, 281147, 322010.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Florida, Minnesota, Switzerland.
QUANTITY a) 1 unit; b) 2 units; c) 1 unit; d) 3 units were distributed.
REASON Blood products tested non-reactive for anti-HIV-2, but were collected from donors who previously tested repeatedly reactive for anti-HIV-2, were distributed.

PRODUCT Panglobulin, Immune Globulin Intravenous (Human), in 12 gram vials.
CODE Lots 01839-00023, 01839-00012.
MANUFACTURER ZLB Central Laboratory, Bern, Switzerland.
RECALLED BY American Red Cross, Rosslyn, Virginia
DISTRIBUTION Nationwide.
QUANTITY 7,963 vials distributed.
REASON Two lots of Immune Globulin Intravenous (Human), that exceeded the residual moisture specification.

PRODUCT Platelets, Pheresis
CODE Unit #LH47927.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had not been questioned about the use of the drug Soriatane (acitretin),

PRODUCT a) Whole Blood; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Platelets, Pooled.
CODE Unit Numbers: a) LX69787; b) Q99456; c) KZ33284; d) FP96554.
MANUFACTURER The Blood center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from donors who had not been questioned about the use of the drug Soriatane (acitretin).

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit Numbers: a) 19GF42933, 19GT17811, 19GG56965, 40GL64478, 40GL64465; b) 19GL16084.
MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY a) 5 units; b) 1 unit was distributed.
REASON Blood products had been stored at unacceptable temperatures.

PRODUCT Platelets
CODE Unit Numbers: 53FN47150, 53T66446, 53FX71803, 53FX71794, 53T66456, 53K29270, 53FX71807.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 7 units were distributed.
REASON Blood products were shipped at an unacceptable temperature.
 

WEEK ENDING NOVEMBER 12

PRODUCT Red Blood Cells, Autologous
CODE Unit #J43291.
MANUFACTURER Blood Assurance, Inc., Chattanooga, Tennessee.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for anti-HCV, and negative by a single repeat test.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Platelets for Use in Manufacturing Non-Injectable Products; f) Recovered Plasma Liquid For Manufacturing Non-Injectable Products; g) Recovered Plasma.
CODE Unit Numbers: a) 31507, 57170, 99944, 118635, 173081, 194857, 285506, 292734, 314544, 354293, 462826, 507843, 0562387, 0594245, 0645267 b) 57170, 99944, 118635, 173081, 194857, 292734, 354293, 0562387; c) 173081, 462826; d) 9005621 e) 507843, 0594245; f) 114331, 14425, 46007, 48744, 90708, 92982, 477357; g) 507843, 31507, 57170, 99944, 194857, 245265, 247572, 285506, 292734, 314544, 354293, 0562387, 0594245, 0645267, 9005621.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota, North Carolina, Ohio, Virginia, California, Florida, Texas, Pennsylvania, Switzerland.
QUANTITY a) 15 units; b) 8 units; c) 2 units; d) 1 unit; e) 2 units; f) 7 units; g) 15 units were distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1, Western blot indeterminate.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma Liquid For Non-Injectable Products; f) Recovered Plasma, Pooled.
CODE Unit Numbers: a) 74271, 163310, 268929, 399080, 92229, 107723; b) 74271, 163310, 268929, 92229, 107723; c) 74271, 268929, 92229, 107723; d) 9007428; e) 399080; f) 9007428.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota, California, Florida.
QUANTITY a) 6 units; b) 5 units; c) 4 units; d) 1 unit; e) 1 unit; f) 1 unit distributed.
REASON Blood products either tested initially reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), or which tested negative for the antibody to the human immunodeficiency virus, but were collected from donors who previously tested repeatedly reactive for either anti-HIV-1 or anti HIV-1/2.

PRODUCT Blood Collection Systems
CODE 50 lot numbers of products manufactured from May 04 through July 05, 1999.
MANUFACTURER Medsep Corporation, a subsidiary of Pall Corporation, Covina, California.
DISTRIBUTION Nationwide and England.
QUANTITY 390,076 units were distributed.
REASON Blood collection bags contained low volumes of anticoagulant.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated; b) Recovered Plasma
CODE Unit #40GE37390.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Proscar.

PRODUCT Salvage Plasma
CODE Unit #7023525.
MANUFACTURER Department of the Air Force, Keesler AFB, Mississippi.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for the antibodies to the human immunodeficiency virus type1/2, and Hepatitis B surface antigen (HBsAG), Hepatitis C virus encoded antigen (anti-HCV), Hepatitis B core antigen (anti-HBc), and syphilis.

PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER Blood Systems, Inc., Tupelo, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Alabama, California, Illinois, Louisiana, Mississippi, New Jersey, New York, Tennessee.
QUANTITY a) 111 units; b) 10 units; c) 14 units; d) 19 units; e) 82 units were distributed.
REASON Blood products were collected from donors whose suitability was not adequately determined.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #19233-2718.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who received weekly injections of gold salt.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit Numbers: 22KV05788, 22GE46099.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 2 unit of each component were distributed
REASON Blood products were collected from donors who reported having lived or traveled in area designated as endemic for malaria.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma.
CODE Unit #03GV11621.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a unsuitable donor.

PRODUCT Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE Unit #0328384-A2.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product had incomplete documentation of irradiation.

PRODUCT Reverse Group 4TM, Pooled Cells for Serum Confirmation of ABO Group; b) Screening Cell PoolTM, for use in detection of unexpected antibodies.
CODE a) Lot 0629 EXP 04 Aug 99; b) Lot 0629, EXP 04 Aug 99.
MANUFACTURER Gamma Biologicals, Inc., Houston, Texas.
DISTRIBUTION Nationwide, Japan, Netherlands, Saudi Arabia.
QUANTITY a) 198 vials; b) 226 vials were distributed.
REASON In-vitro diagnostic products were contaminated with Serratia marcesans.

PRODUCT Red Blood Cells, Irradiated, Leukocytes Reduced.
CODE Unit #X46547.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Sandoglobulin IV, Immune Globulin Intravenous (Human), in 12 gram vials, indicated for the maintenance treatment of patients with primary immunodeficiencies.
CODE Lot number on box (lot number on vial): #561Z4409 (7.409.561.0), 029A6093 (8.409.208.0), 047A6478 (8.409.362.0), 053A6697 (8.409.433.0), 053A6698 (8.409.433.0), 072A8945 (8.409.599.0), 080B9812 (9.409.229.0), 085B9813 (9.401.255.0), 090B0161 (9.401.292.0), 561Z4098 (7.409.561.0), 072A8946 (8.409.599.0).
MANUFACTURER ZLB Central Laboratory, Bern, Switzerland.
RECALLED BY Novartis, East Hanover, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 24,585 vials were distributed.
REASON Eleven lots of Immune Globulin Intravenous (Human) exceeded the residual moisture specification.

PRODUCT Recovered Plasma
CODE Unit #2549185.
MANUFACTURER Department of Army, Armed Services Blood Bank Center, Tacoma, Washington.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported taking the drug mesalamine.
 

WEEK ENDING NOVEMBER 26

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma
CODE Unit Numbers: a) 04H71124, 04J96323; b) 04H71124, 04J96323; c) 04H71124; d) 04J96323.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION New York, Maine, Massachusetts, California.
QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 1 unit.
REASON Blood products were collected from an unsuitable donor.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit Numbers: a) 22LQ61516, 22GZ73653; b) 22LQ61516; c) 22LQ61516.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were not quarantined after receiving information concerning a post donation illness.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF.
CODE Unit #30GH25982.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
DISTRIBUTION Pennsylvania and Massachusetts.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor diagnosed with Mycosis Fungoides.

PRODUCT Red Blood Cells, Leukoreduced
CODE Unit #03KQ06498.
MANUFACTURER American Red Cross Blood Services, Savannah, Georgia.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had been deferred for a history of antibiotic therapy.

PRODUCT a) Red Blood Cells; b) Platelets; c) Plamsa, Cryoreduced; d) Cryoprecipitated AHF; e) Recovered Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York, Pennsylvania, Florida.
QUANTITY a) 39 units; b) 23 unit; c) 1 unit; d) 1 unit; e) 32 units were distributed.
REASON Blood products that were not tested for syphilis and unexpected antibodies.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit #19235-6429.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was mislabeled as CMV antibody negative.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #19021-5133.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Illinois, Nevada, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had previously been deferred after requesting that a donation be identified for confidential self exclusion.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 0467203, 0467181, 0123666, 0123842.
MANUFACTURER Euroblood Center, Amsterdam, Netherlands.
RECALLED BY New York Blood Services (Center West), New York, New York
DISTRIBUTION New Jersey and New York.
QUANTITY 4 units were distributed.
REASON Blood products were collected from donors who previously tested reactive for syphilis within one year of donation.

PRODUCT Platelets
CODE Unit #22KR45359.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted red blood cells.

PRODUCT a) Whole Blood; b) Red Blood Cells; c) Red Blood cells, Leukocytes Reduced; d) Fresh Frozen Plasma; e) Platelets; f) Platelets, Pheresis; g) Recovered Plasma; h) Recovered Plasma for further Manufacturing of Non-Injectable Products; i) Red Blood Cells for Further Manufacturing.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio, Michigan, Idaho, Missouri, California, Switzerland.
QUANTITY a) 1 unit; b) 186 units; c) 52 units; d) 151 units; e) 161 units; f) 31 units; g) 78 units; h) 22 units; i) 6 units were distributed.
REASON Blood products were not tested for the HIV-1 p24 antigen in accordance with the test kit manufacturer's instructions.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Platelets, Pheresis; e) Cryoprecipitated AHF; f) Plasma, Cryo Poor; g) Recovered Plasma; h) Red Blood Cells for Manufacturing Use Only; i) Recovered Plasma Liquid For Manufacturing Non-Injectable; j) Platelets for Use in Manufacturing Non-Injectable Products.
CODE Unit Numbers: a) 249279, 265000, 291998, 298140, 348672 b) 334033; c) 249279, 265000, 298140, 334033, 348672 d) 207400, 218802, 226184, 232371, 243800, 251608, 342920, 346872; e) 291998; f) 291998; g) 249279, 265000, 298140, 334033, 348672, 207400, 243800, 346872; h) 278812;
i) 185666, 194326, 194936, 196973, 197389, 197593, 198549; j) 196973, 268911, 278812, 323836.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION California, Florida, Minnesota, New Jersey, Pennsylvania, Switzerland.
QUANTITY a) 5 units; b) 1 unit; c) 5 units; d) 8 units; e) 1 unit; f) 1 unit; g) 8 units; h) 1 unit; i) 7 units; j) 4 units were distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1/2 (anti-HIV-1/2), but were collected from donors who previously tested repeatedly reactive for anti-HIV-2.

PRODUCT Recovered Plasma
CODE Unit #30GH25982.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor diagnosed with Mycosis Fungoides.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit #19236-2697.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had an elevated body temperature.

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit Numbers: 16333-7131, 16333-7132, 16333-7133, 16333-7134, 16334-5938, 16340-5551, 16340-5896, 16340-5897, 16340-5899, 16340-5900, 16340-5901, 16340-6282, 16340-7565, 16340-8695, 16340-8708, 16341-3035, 16341-3100, 16341-3102, 16341-3104, 16342-0096, 16342-0097, 16342-0098, 16342-0099, 16342-0101, 16342-0352, 16342-8743, 16343-6682, 16343-6683, 16343-6684, 16343-6685, 16343-6687, 16343-8624, 16343-8626, 16344-2112, 16344-2113, 16344-3545, 16344-3041, 16344-3042, 16344-3043, 16344-4445, 16344-4446, 16344-4447, 16344-9258, 16344-9259, 16344-9261.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi.
QUANTITY 45 units were distributed.
REASON Red Blood Cells, leukoreduced by filtration greater than 72 hours past the time of collection, were distributed for transfusion.

PRODUCT Red Blood Cells, Irradiated, Low Volume
CODE Unit Numbers: 22LY61409, 22LQ68923, 22LQ69111, 22KC06664, 22KY29843.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 5 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Red Blood Cells
CODE 26159-4806, 26159-4808, 26159-4814.
MANUFACTURER United Blood Services, Fort Smith, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arkansas and Oklahoma.
QUANTITY 3 units were distributed.
REASON Blood products were labeled with extended expiration dates.