WEEK ENDING AUGUST 6

PRODUCT Normal Saline with Phenol, Sterile Diluent for Allergenic Extract.
CODE Lot #5772.
MANUFACTURER Allergy Laboratories, Inc., Oklahoma City, Oklahoma.
DISTRIBUTION Texas and Missouri.
QUANTITY 17,400 vials were distributed.
REASON Diluent, marketed for use with allergenic extracts were underfilled.

PRODUCT Red Blood Cells.
CODE Unit #11GM05568.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported living in an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit #G47469.
MANUFACTURER Mississippi Valley Blood Center, Davenport, Iowa.
DISTRIBUTION Colorado, Iowa, Pennsylvania.
QUANTITY 1 unit of each component was distributed
REASON Blood products were collected from a donor taking the drug, Arthrotec at the time of donation.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit #21GY48739.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Massachusetts, California, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested repeatedly reactive for anti-HCV.

PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma.
CODE Unit #21GC45925.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION California, Puerto Rico, Oregon.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with Multiple Sclerosis.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit numbers: 31LG07155 through 31LG07182.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York, Pennsylvania, California, Switzerland.
QUANTITY a) 28 units; b) 26 units were distributed.
REASON Blood products were incorrectly tested for syphilis.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #39G01526.
MANUFACTURER American Red Cross, Huntington, West Virginia.
DISTRIBUTION West Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were mislabeled as CMV antibody negative.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #11GN00668.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF c) Cryoreduced Plasma; d) Source Leukocytes.
CODE Unit #11GS18604.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Alabama, Maryland, Missouri, New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of Hepatitis C.

PRODUCT a) Platelets, Pheresis; b) Platelets.
CODE Unit #11P33093, 11P32959, 11P32838 (parts I & II); b) 11P32405.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Illinois and Missouri.
QUANTITY a) 3 units; b) 1 unit.
REASON Blood products were collected from a donor with a history of having tested reactive for HIV and Hepatitis.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit numbers: a) 11-147280; b) 11-147280 and 11-159274.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and New York.
QUANTITY a) 1 unit; b) 2 units were distributed.
REASON Blood products tested negative for the hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested repeatedly reactive for HBsAg and had a history of hepatitis.

PRODUCT Source Leukocytes for Manufacturing Use Only.
CODE Unit #11GM05568.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported living in an area designated as endemic for malaria.

PRODUCT Pooled Plasma, Solvent Detergent Treated (PLAS+SD).
CODE Lot #FW80602.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio.
QUANTITY 102 units were distributed.
REASON Failure to quarantine blood products that were not manufactured according to the product license.

PRODUCT Whole Blood.
CODE Unit #21R50028.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with extended expiration date.

PRODUCT Human Corneas for Transplant.
CODE Unit numbers: 99-151OD and 99-151OS.
MANUFACTURER Erie County Medical Center (ECMC) Clinical Laboratories, Buffalo, New York (contract testing laboratory).
RECALLED BY Upstate New York Transplant Services, Inc. (UNYTS)
DISTRIBUTION New York.
QUANTITY 2 corneas.
REASON Corneas were collected from a donor who tested repeatedly reactive for HCV with a negative RIBA test.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Cryoprecipated AHF; e) Recovered Plasma.
CODE Unit Numbers: a) 6279995, 6744054, 6747023, 6748067, 6770078, 6789722, 7439337, 7629762, 7631177; b) 6553674; c) 7629762, 6748067;
d) 6770078; e) 6279995, 6744054, 6747023, 6748067, 6770078, 6789722, 7439337, 7629762, 7631177.
MANUFACTURER New York Blood Services (Center West), New York, New York.
RECALLED BY New York Blood Center, Inc., New York, New York
DISTRIBUTION New York, New Jersey, Switzerland.
QUANTITY a) 9 units; b) 1 unit; c) 2 units; d) 1 unit; e) 9 units were distributed.
REASON Blood products were collected from donors who initially tested negative for HIV I/II, but retrospectively tested repeatedly reactive for HIV I/II, with a negative Western Blot, or indeterminate Western Blot with a negative PCR test, and two subsequent donations from such donors that tested negative for HIV I/II.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed; c) Platelets; d) Platelets, Pooled; e) Platelets Pheresis; f) Plasma; g) Plasma, Liquid; h) Fresh Frozen Plasma; i) Cryoprecipitate AHF; j) Cryoprecipitate AHF. Pooled; k) Source Plasma; l) Recovered Plasma; m) Red Blood Cells for Further Manufacture Non Injectable.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. PRIVATE MANUFACTURER American Red Cross National Testing Laboratory, Detroit, Michigan. (testing laboratory).
RECALLED BY American Red Cross Blood Services, Columbus, Ohio
DISTRIBUTION Ohio, New Jersey, Michigan, Illinois, Maryland, Massachusetts, Arkansas, California, Puerto Rico, California, Switzerland.
QUANTITY a) 162 units; b) 1 unit; c) 87 units; d) 7 units; e) 27 units; f) 6 units; g) 3 units; h) 24 units; i) 24 units; j) 8 units; k) 3 units; l) 143 units; m) 6 units were distributed.
REASON Blood products were tested for the HIV-1 p24 antigen in a manner that was not in conformance with the manufacturers instructions.
 

PRODUCT Ficin -treated Red Blood Cells packaged in the Gamma Ficin Panel System.
CODE Lot Number 0126.
MANUFACTURER Gamma Biological, Inc., Houston, Texas.
DISTRIBUTION New York and Hawaii.
QUANTITY 2 Ficin Panel Systems marketed.
REASON Reagent Red Blood Cells were microbially contaminated.

PRODUCT Recovered Plasma.
CODE Unit #11LX60194.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving information concerning a post donation illness.

PRODUCT Platelets.
CODE Unit Numbers: 18219-0393 and 18219-2123.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Maryland and North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood products were prepared from units of whole blood identified as a difficult draw.
 

WEEK ENDING AUGUST 13

PRODUCT Red Blood Cells
CODE Unit #11KC01556.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving information concerning a post donation illness.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers 11LY97348, 11LY89722, 11LV20309.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri. California, Switzerland.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit Numbers: 21Y44492, 21Y51404, 21GK75498 and 21FK96033.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Oregon, Massachusetts, Minnesota, California, Switzerland.
QUANTITY 4 units of each component were distributed.
REASON Blood products were collected from a donor with a history of cancer.

PRODUCT Red Blood Cells
CODE Unit #01LS03577
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Recovered Plasma
CODE Unit 3Y1534.
MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the Proscar.

PRODUCT Recovered Plasma
CODE Unit #8B9004.
MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor whose suitability was not adequately determined.

PRODUCT Defense Blood Standard System (DBSS), Blood Bank Software.
CODE Software Versions 3.00 and 3.01.
MANUFACTURER Electronic Data Systems (EDS), Herndon, Virginia.
RECALLED BY U.S. Department of Defense (DBSS)\Composite Health Care System 2, Falls Church, Virginia
DISTRIBUTION Nationwide and international.
QUANTITY Utilized at 78 sites.
REASON Blood bank computer software does not identify all potential duplicate donor records.

PRODUCT a) Red Blood Cells; b) Plasma, Frozen.
CODE Unit #40GC37973.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma
CODE Unit numbers: a) J31286, J45663, J58685, K06572, K46076, K65502, K85869, L05436; b) J45663, J58685, J88524, K46076, K65502, K85869, L05436; c) J88524; d) J31286, J45663, K06572, K46076, K65502, L05436.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Illinois, California, North Carolina, Virginia.
QUANTITY a) 8 units; b) 7 units; c) 1 unit; d) 6 units were distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot negative.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma
CODE Unit Numbers: a&c) 7630391, 7802540; b) 7802540.
MANUFACTURER New York Blood Services (Center West), New York, New York.
RECALLED BY New York Blood Center, Inc., New York, New York
DISTRIBUTION New York, New Jersey, Switzerland.
QUANTITY a&c) 2 units of each component; b) 1 unit.
REASON Blood products initially tested negative for HCV, but retrospectively tested repeatedly reactive for HCV, with a negative RIBA, or indeterminate RIBA with a negative PCR test.

PRODUCT Fresh Frozen Plasma
CODE Unit #8D8447.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product, collected from a donor who took the drug Propecia.

PRODUCT Red Blood Cells, Apheresis, double bag
CODE Unit Numbers: 8959701, 8950506, 8950504, 8961576, 8961577.
MANUFACTURER New York Blood Services (Westside), New York, New York.
DISTRIBUTION New York.
QUANTITY 5 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit numbers 6515231 and 6755680.
MANUFACTURER New York Blood Services (Center West), New York, New York.
RECALLED BY New York Blood Center, Inc., New York, New York
DISTRIBUTION New York, New Jersey, Switzerland.
QUANTITY 2 units of each component was distributed.
REASON Blood products initially tested negative for HCV, but retrospectively tested repeatedly reactive for HCV, with a negative RIBA, or indeterminate RIBA with a negative PCR test.

PRODUCT Recovered Plasma
CODE Unit #11FN77060.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose arm inspection may not have been satisfactory.
 

WEEK ENDING AUGUST 20

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Platelets Pheresis; e) Recovered Plasma.
CODE Unit numbers: a) 11L02397, 11L19669; b) 11L02397, 11L19669; c) 11L19669; d) 11P72284, 11P72799, 11P74102; e) 11L02397.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri.
QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 3 units; d) 1 unit.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested reactive for the antibody, Western Blot indeterminate.

PRODUCT Corneas
CODE Donor numbers: 94-001 (PRF), 94-001, 94-002, 080594-003 OD, 080594-004 OS, 1024094(94003), L2113094, R1113094, 032995-05, 032995-06, 96-030201, 96-030292, 97-011-OD, 97-012-OS.
MANUFACTURER Lions Eye Bank, Inc., San Angelo, Texas.
DISTRIBUTION Texas, Guatemala, Mexico.
QUANTITY 14 corneas.
REASON Corneas from donors who were not tested for anti-HIV-2, and in some cases also lacked the donor's social/medical history.

PRODUCT Platelets, Irradiated
CODE Unit #20270-1343.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product for which documentation of irradiation was incomplete.

PRODUCT Left and Right Corneas
CODE PA-20647-RC, PA-20647-LC.
MANUFACTURER Lions Eye Bank of Delaware Valley, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 2 corneas.
REASON Corneas were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (ant-HBc).

PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF.
CODE Unit numbers: a) 27GP00623, 27L86365, 27FQ28370; b) 27GP00623, 27FQ28370; c) 27L86365.
MANUFACTURER American Red Cross Blood Services, Johnstown, Pennsylvania.
DISTRIBUTION Maryland, Pennsylvania, West Virginia.
QUANTITY a) 3 units; b) 2 units; c) 1 unit.
REASON Blood products were collected from a donor taking the drug Methotrexate.

PRODUCT a) Platelets, Pheresis; b) Fresh Frozen Plasma.
CODE Unit #27P35660.
MANUFACTURER American Red Cross Blood Services, Johnstown, Pennsylvania.
DISTRIBUTION Pennsylvania and West Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was participating in a flu vaccine study.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #22381-2195.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT Corneas
CODE Donor numbers: 1028-98 and 1029-98.
MANUFACTURER The Eye Bank for Sight Restoration, Inc., New York, New York.
DISTRIBUTION New York.
QUANTITY 2 corneas.
REASON Corneas were collected from a donor who had not been properly evaluated for the effect of serodilution on the plasma samples used for infectious disease testing.

PRODUCT Albumin (Human) 25%, 50 mL, Plasbumin-25 brand; b) Albumin (Human) 5%, 250 mL, Plasbumin-5 brand.
CODE a) Lot 684R066; b) Lot 685R048.
MANUFACTURER Bayer Corporation, Clayton, North Carolina.
DISTRIBUTION Arizona, California, Florida, Illinois, Indiana, Kentucky, Minnesota, New Jersey, Pennsylvania, South Carolina, Tennessee, Texas, Washington state.
QUANTITY a) 16,467 vials; b) 7,493 vials were distributed.
REASON Testing found that two lots of Albumin had Prekallikrein Activator (PKA) levels which exceeded that allowed by the product's licenses.

PRODUCT Platelets, Pheresis
CODE 27P28144, 27P28774, 27P29429, 27P29986, 27P30674, 27P32050, 27P33105, 27P33787, 27P35565, 27P36709, 27P37196.
MANUFACTURER American Red Cross Blood Services, Johnstown, Pennsylvania.
DISTRIBUTION Pennsylvania and West Virginia.
QUANTITY 11 units were distributed.
REASON Blood products were labeled with the incorrect human leukocyte antigen (HLA) typing.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #29KM06488.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who lived in Nigeria

PRODUCT Red Blood Cells
CODE Unit #K66643.
MANUFACTURER Nueces County Medical Community Blood Bank, Corpus Christi, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving information concerning a post donation illness.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #29FT81183.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION Virginia, North Carolina, California.
QUANTITY 1 unit of each component was distributed,
REASON Blood products were collected from a donor who provided post donation information regarding having engaged in high risk behaviors.

PRODUCT Red Blood Cells
CODE Unit #22398-8423.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
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 #22397-9341.
MANUFACTURER Blood Services, Inc., Las Vegas, California.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
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 a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets.
CODE Unit #8006949.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody.

PRODUCT Red Blood Cells
CODE Unit #40FE49621.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who visited an area designated as endemic for malaria.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE 40P68370, 40P67905, 40P67234.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Illinois and Arkansas.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells
CODE Unit numbers: 40GC37217.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Missouri and Massachusetts.
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 #18219-1591.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION California.
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, Washed, Irradiated
CODE Unit #22400-8360.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Source Plasma
CODE Unit #00127370.
MANUFACTURER Sera-Tec Biologicals Limited Partnership, Pittsburgh, Pennsylvania.
RECALLED BY Sera-Tec Biologicals Limited Partnership, North Brunswick, New Jersey
DISTRIBUTION Product was in transit to Baxter-Hyland.
QUANTITY 1 unit.
REASON Blood product tested repeatedly reactive for the HIV-p24 antigen.

PRODUCT Platelets
CODE Unit #27FN58504.
MANUFACTURER American Red Cross Blood Services, Johnstown, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT a) Red Blood Cells ; b) Red Blood Cells, Leukocytes Removed; c) Platelets; d) Platelets Pheresis; e) Fresh Frozen Plasma; f) Plasma; g) Cryoprecipitate AHF; h) Recovered Plasma; i) Red Blood Cells for Manufacture of Non Injectables.
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Idaho, Ohio, New York, Massachusetts, Michigan, Wisconsin, Pennsylvania, Illinois, Minnesota, Tennessee, Georgia, Maryland, Puerto Rico, California, Switzerland.
QUANTITY a) 282 units; b) 16 units; c) 156 units; d) 23 units; e) 21 units; f) 1 unit; g) 18 units; h) 242 units; i) 1 unit.
REASON Blood products were tested for the HIV-1 p24 antigen in a manner that was not in conformance with the manufacturer's instructions.

PRODUCT Fresh Frozen Plasma
CODE Unit #0824274.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Fresh frozen plasma was not separated and frozen within eight hours of phlebotomy.

PRODUCT a) Platelets; b) Recovered Plasma
CODE Unit #3X5680.
MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington.
DISTRIBUTION Washington state and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who took the drug Propecia.

PRODUCT a) Platelets; b) Recovered Plasma
CODE Unit #3Y3219.
MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington.
DISTRIBUTION Washington state and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who took the drug Propecia.

PRODUCT Red Blood Cells
CODE Unit #5151468.
MANUFACTURER BloodCare, doing business as Carter BloodCare, Dallas, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who did not answer all of the pre-donation screening questions.