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FDA biologic recalls

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 222 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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1 recall that day

HCSC-Blood Center Plasma and Red Blood Cells

Red Blood Cells, Leukocytes Reduced were collected from a donor with incomplete eligibility screening.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

15 recalls that day

Penn State Health Holy Spirit Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed with incomplete testing.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor taking Proscar.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99694

American National Red Cross Red Blood Cells, Leukocytes Reduced, Irradiated

The product was misbranded.

Moderate risk, FDA, Ended, Hospital use, Mislabeled product

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had taken Accutane.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99693

OneLegacy Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99928

Eversight Illinois Cornea

Cornea was distributed without adequate donor eligibility determination.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99927

OneLegacy Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99926

San Antonio Eye Bank Cornea

A mislabeled cornea was distributed.

Moderate risk, FDA, Ended, Hospital use, Labeling error

South Dakota Lions Eye Bank Cornea

Corneas were recovered from a donor not adequately tested to reduce the risk of transmitting communicable diseases.

Low risk, FDA, Ended, Hospital use, Donor screening problem

Lions Eye Bank of Nebraska Cornea

Corneas were distributed from a donor whose eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Tissue Transplant Technology Bone

Bone products were processed in a manner that could cause contamination or spread of communicable disease.

Moderate risk, FDA, Ended, Hospital use, Contamination

American Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested positive.

Moderate risk, FDA, Ended, Hospital use, Labeling error

ImpactLife Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

American National Red Cross Apheresis Platelets and Red Blood Cells

Apheresis Platelets and Red Blood Cells were out of monitored storage for an extended period.

Low risk, FDA, Ended, Hospital use, Processing problem

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were leukoreduced by filtration at an unacceptable temperature.

Low risk, FDA, Ended, Hospital use, Processing problem

20 recalls that day

ARUP Laboratories Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor taking an unlicensed, unapproved, or experimental medication.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

American National Red Cross Apheresis Platelets

Apheresis Platelets were distributed without being tested for pH or platelet yield.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99624

Vitalant Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed from a donor with travel history to a malaria endemic area but not assessed for residency.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

CorneaGen - Boston Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99913

Iowa Lions Eye Bank Cornea

Corneas processed using an expired viewing chamber were distributed.

Moderate risk, FDA, Ended, Hospital use

CorneaGen - Boston Cornea

Corneas were distributed from a donor whose eligibility determination failed to ensure the donor was free from risk factors for communicable diseases.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99922

OneLegacy Cornea

Corneas were distributed from a donor whose eligibility determination failed to ensure the donor was free from risk factors for communicable diseases.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99919

Rocky Mountain Lions Eye Bank Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Eversight Cornea

Cornea was distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Precision Ocular Network - Bartlett Cornea

Corneas were recovered from a donor whose eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99916

Precision Ocular Network - Bartlett Cornea

Corneas were recovered from a donor whose eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99915

Eversight Illinois Cornea

Corneas were not tested adequately to reduce the risk of transmitting communicable diseases.

Low risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99912

Department of Defense Navy Whole Blood

Whole Blood tested negative for a virus antibody but was collected from a donor who previously tested positive.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

HCSC-Blood Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were exposed to unacceptable storage temperatures.

Low risk, FDA, Ended, Hospital use, Processing problem

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were incorrectly labeled as irradiated and distributed.

Moderate risk, FDA, Ended, Hospital use, Labeling error

Department of Defense Air Force Red Blood Cells

Red Blood Cells were collected from a donor who previously tested repeatedly reactive for HTLV-I antibody.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor with low hemoglobin or no hemoglobin check.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98849

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98848

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 98800

Eversight Illinois Cornea

Cornea was processed without the proper antibiotic soak.

Moderate risk, FDA, Ended, Hospital use, Processing problem, FDA event number 95801

1 recall that day

American National Red Cross Red Blood Cells and PF24 Plasma

American National Red Cross Red Blood Cells and PF24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

Moderate risk, FDA, Ended, Hospital use, Sterility problem

4 recalls that day

American National Red Cross Apheresis Plasma

Apheresis PF24RT24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

Moderate risk, FDA, Ended, Hospital use, Sterility problem

American Natl. Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed from a donor with travel history to a malaria endemic area but not assessed for residency.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Innovative Blood Resources Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who previously tested reactive for Hepatitis B core antigen.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

American National Red Cross Red Blood Cells and Pooled Cryoprecipitated AHF

The products were collected from a donor who previously tested reactive for the antibody to Hepatitis B core antigen on more than one occasion.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

2 recalls that day

New York Blood Center Enterprises Plasma and Red Blood Cells

Plasma and red blood cells were collected in expired collection kits and distributed.

Low risk, FDA, Ended, Hospital use

LifeShare Blood Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had a platelet count higher than acceptable.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced may have been exposed to unacceptable temperatures due to extended transit time.

Moderate risk, FDA, Ended, Hospital use, Processing problem, FDA event number 99502

American National Red Cross PF24 Plasma and Red Blood Cells

Red blood cells and plasma were distributed after donors' arm inspections were not properly performed.

Low risk, FDA, Ended, Hospital use, Donor screening problem

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99488

3 recalls that day

Stanford Blood Center Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex were collected with potential air contamination.

Moderate risk, FDA, Ended, Hospital use, Contamination

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

The product did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99487

Medic Apheresis Platelets and Platelets Extended Dating

Apheresis Platelets, Leukocytes Reduced, Irradiated, with a platelet count higher than was acceptable, were distributed.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

1 recall that day

Vitalant Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem