WEEK ENDING DECEMBER 3

PRODUCT Platelets, Pheresis.
CODE Unit Numbers: 19235-6459-01, 19235-6459-02, 19235-3178-01, 19235-3178-02, 19236-1495-01, 19236-1495-02.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 6 units were distributed.
REASON Blood products had high platelet counts.

PRODUCT Platelets
CODE Unit #22KY31021.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with the incorrect ABO group.

PRODUCT Red Blood Cells, Frozen.
CODEUnit #5566482.
MANUFACTURER Naval Hospital Blood Bank, Jacksonville, Florida.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood tested negative for the hepatitis B surface antigen (HBsAg), but was collected from a donor who previously tested reactive for HBsAg, with no confirmatory testing.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma
CODE Unit Numbers: a) 22KT11794, 22FQ38860; b) 22KT11794; c) 22KT11794; d) 22KE92044.
MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania, New Jersey, Texas, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit.
REASON Blood products, collected from three donors with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma.
CODE Unit numbers: a) 19033-3563, 19226-8287; b) 19226-8287; c) 19033-3563.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada and Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit was distributed.
REASON Blood product were collected from a donor with a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Source Leukocytes; c) Recovered Plasma.
CODE Unit #53LL21809.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland, New Jersey, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who lived in a household with someone who had tested positive for HIV and Hepatitis B.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets; d) Platelets for Further Manufacture; e) Recovered Plasma.
CODE Unit Numbers: a) 2214742, 2216330; b) 2214742; c) 2214742; d) 2216330 ;e) 2216330.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 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 repeatedly reactive for the antibody, Western Blot negative.
 

WEEK ENDING DECEMBER 10

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF
CODE Unit #6661043.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
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 reactive for Hepatitis C.

PRODUCT a) Red Blood Cells, Irradiated; b) Recovered Plasma.
CODE Unit #9642321.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was 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) Recovered Plasma.
CODE Unit Numbers 8604912, 8604643.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units of each component 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) Fresh Frozen Plasma.
CODE Unit #1343973.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of cancer.

PRODUCT Red Blood Cells
CODE Unit Number 3154761.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had previously been deferred for IV drug use.

PRODUCT Red Blood Cells, Leukocyte Reduced
CODE Unit #2772335.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Platelets
CODE Unit #6705688.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product, which tested positive for unexpected antibodies, was labeled as being negative for unexpected antibodies.

PRODUCT Red Blood Cells
CODE Unit Number 15006-5292.
MANUFACTURER Blood Services, Lubbock, Texas.
RECALLED BY United Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who reported taking the drug Asacol (mesalamine).

PRODUCT Platelets, Pheresis, Leukoreduced
CODE Unit Number 04FP45664 - split unit.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts
QUANTITY 1 unit was distributed.
REASON Blood products, which had high platelet counts, were distributed.

PRODUCT Red Blood Cells, Leukoreduced
CODE Unit Numbers 04KS36131 and 04KS36136.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY 2 units were distributed.
REASON Blood products had no documentation of having been leukoreduced.

PRODUCT Red Blood Cells.
CODE Unit #04F57231.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION 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 a) Red Blood Cells; b) Plasma, Liquid; c) Recovered Plasma.
CODE Unit Numbers: a) 04C97984, 04GK23684, 04GK25686, 04GK29178; b) 04GK25686; c) 04C97984, 04GK23684, 04GK29178.
MANUFACTURER American Red Cross, New England Region, Dedham, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY a) 4 units; b) 1 unit; c) 3 units.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers 04FC66562.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Connecticut and California.
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) Recovered Plasma.
CODE Unit #04H78912.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of cancer.

PRODUCT Source Plasma
CODE Unit Numbers 970257848, 970257785, 970257598, 970257509, 970256220, 970256076, 970255919.
MANUFACTURER SeraCare, Inc., Boise, Idaho.
DISTRIBUTION New Jersey.
QUANTITY 7 units were distributed.
REASON Blood products were not quarantined after one donor tested reactive for anti-HCV, and another donor provided post donation information regarding having been incarcerated.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Frozen Plasma, For Research Use Only.
CODE Unit Numbers a) J29412, J28813, J28743, J28801, J28747, J28794, J28816, J28756, J32367, J32368; b) J29412, J28801, J28816, J28794, J28813, J28756; c) J29877, J29936, J29967.
MANUFACTURER UCLA Medical Center Blood Bank, Los Angeles, California.
DISTRIBUTION California.
QUANTITY a) 10 units; b) 6 units; c) 3 units were distributed.
REASON Blood products were not tested for viral markers in accordance with the test kit manufacturers instructions.

PRODUCT Red Blood Cells
CODE Unit #20272-1964.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana.
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 Platelets, Pheresis
CODE Unit Numbers 20271-6871, 20272-9771-02.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona.
DISTRIBUTION Illinois and Louisiana.
QUANTITY 2 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCTS Platelets, Pheresis
CODE Unit #20273-3674-01.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT Platelets, Pheresis
CODE Unit #20275-2038-01.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed.
REASON Blood products had an unacceptable platelet count.

PRODUCT Platelets, Pheresis. Recall #B-226-0.
CODE Unit Numbers: 15006-1130-01, 1506-1130-02.
MANUFACTURER United Blood Services, Lubbock, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood products had an unacceptable platelet count.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit Numbers 19237-2461, 19237-9041; b) 19237-2461.
MANUFACTURER United Blood Services, Reno, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY a) 2 units; b) 1 unit were distributed.
REASON Blood products were collected from a donor taking the drug Zyprexa (Olanzapine).

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced.
CODE Unit Numbers a) 21KM03667; b) 21KM01402.
MANUFACTURER American Red Cross, Bend, Oregon.
RECALLED BY American Red Cross, Portland, Oregon
DISTRIBUTION Oregon, California.
QUANTITY a) 1 unit; b) 1 unit was distributed.
REASON Blood products was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells
CODE Unit Number 21GC58532.
MANUFACTURER American Red Cross, Portland, Oregon.
DISTRIBUTION Washington state.
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 #21KL06049.
MANUFACTURER American Red Cross, Portland, Oregon.
DISTRIBUTION California, Michigan.
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. Recall #B-235-0.
CODE Unit Numbers 21KL08793, 21KJ13423.
MANUFACTURER American Red Cross, Portland, Oregon.
DISTRIBUTION Washington state, Oregon.
QUANTITY 2 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 20272-6938.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Tennessee.
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 a) Red Blood Cells; b) Platelets
CODE Unit Numbers a) 20272-8613; b) 20272-3362.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY lood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY a) 1 unit; b) 1 unit.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Platelets, Pheresis
CODE Unit Numbers 04GP40543(P1), 04GP40543(P2).
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Pennsylvania, West Virginia.
QUANTITY 2 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT Recovered Plasma
CODE Unit Number 20277-1635.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that compromised the sterility of the unit.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma
CODE Unit Number 04KK06368.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Maine, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit Numbers: a) 01Y25374; b) 01Y25364, 01Y25366, 01Y25368, 01Y25370, 01Y25371.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York.
QUANTITY a) 1 unit; b) 5 units were distributed.
REASON Blood products were incorrectly tested for syphilis and ALT.

PRODUCT Platelets
CODE Unit #01GC22607.
MANUFACTURER American Red Cross Blood Services, Syracuse, New York.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells that was positive for Serratia liquifaciens.

PRODUCT a) Red Blood Cells; b) Platelets Pheresis.
CODE Unit Numbers: 03LN17915, 03LW17769, 03FQ14238, 03FQ14240; b) 03LL11727, 03FG15515, 03LQ14704.
MANUFACTURER American National Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia.
QUANTITY a) 4 units; b) 3 units were distributed.
REASON Blood products were not tested for the anti-HIV-1 Antigen in accordance with the test kit manufacturer's instructions.

PRODUCT Whole Blood, CPDA-1
CODE Unit #3176568.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit Numbers 6115399, 6115412.
MANUFACTURER The Community Blood Center, Incorporated, Appleton, Wisconsin.
DISTRIBUTION Wisconsin.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Platelets
CODE Unit #11322-5194.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product, prepared from a unit of whole blood identified as a difficult draw.

PRODUCT Platelets
CODE Unit #20276-6440.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana.
QUANTITY 1 unit was distributed
REASON Blood product was prepared from a unit of whole blood identified as a difficult draw.

PRODUCT Ragweed Mix GS, (Giant and Short) Antigen E, labeled as 320 units/ml, 40,000 PNU mL, in 50 ml vial
CODE Lot #J99E9462.
MANUFACTURER Bayer Corporation, Pharmaceutical Division, Elkhart, Indiana. (U.S. Distributor)
RECALLED BY Hollister-Stier Laboratories, LLC, Spokane, Washington
DISTRIBUTION New Jersey, Washington D.C.
QUANTITY 18 vials were distributed.
REASON Allergenic extracts with an Antigen E value of 107.56 units/mL were labeled as having an Antigen E content of 320 units/mL.

PRODUCT Recovered Plasma
CODE Unit #01GC22607.
MANUFACTURER American Red Cross Blood Services, Syracuse, New York.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of red blood cells that was positive for Serratia liquifaciens
 

WEEK ENDING DECEMBER 24

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma
CODE
Unit Numbers: a) 03C34851, 03F45182, 03F53434, 03F79693, 03FJ17549, 03FJ18002, 03FL02115, 03FT04239, 03GG40657, 03GT14518,
03K76755, 03M36238, 03N78550, 03X05797
b) 03C34851, 03F45182, 03F53434, 03F79693, 03FJ17549, 03FL02115, 03FT04239, 03GG40657, 03K76755, 03N78550, 03S00658, 03X05797
c) 03F79693, 03FJ18002, 03FL02115, 03GG40657, 03GT14518, 03X05797
d) 03C34851, 03F45182, 03F53434, 03FJ17549, 03FT04239, 03K76755, 03M36238, 03N78550.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia, Alabama, Florida, California.
QUANTITY a) 14 units; b) 12 units; c) 6 units; d) 8 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis A.

PRODUCT Platelets, Pheresis
CODE Unit #4502429.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cells.
CODE Unit #17189-3330.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
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) Buffy Coat; d) Recovered Plasma
CODE Unit #53Y72032.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland, New Jersey, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER United States Air Force, Bitburg, Germany.
DISTRIBUTION U.S. Military Blood Clearinghouses in Europe.
QUANTITY 153 units were distributed.
REASON Blood products were tested for HBsAg using an unlicensed test kit.

PRODUCT a) Platelets, Pheresis Leukocytes Reduced; b) Platelets, Pheresis
CODE Unit Numbers: a) 8504739; b) 8504782 part A, 8504782 part B.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY a) 1 unit; b) 1 split unit.
REASON Blood products tested negative for HBsAg, but were collected from a donor who previously tested reactive for HBsAg.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma for Further Manufacture; c) Recovered Plasma
CODE Unit Numbers: a)7309724, 4332103 b) 7309724 c) 4332103.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida and Canada.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit.
REASON Blood products, collected from donors who received monetary payment for donating and were labeled as volunteer donations, were distributed prior to completion of viral marker testing.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #20269-7059.
MANUFACTURER Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Louisiana and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura.

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit #53K32310.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Red blood cells, leukocytes reduced by filtration greater than five days past the time of collection, was distributed.