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Biologic recalls tagged "Donor screening problem"

Recalls of blood, tissue, vaccines and related products regulated by FDA’s biologics center, newest first. 82 recalls Dates are when each recall was announced (how we date recalls).
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1 recall that day

New York Blood Center Enterprises Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated tested repeatedly reactive for anti-HCV and were distributed.

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

1 recall that day

American National Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor deferred for accidental blood exposure.

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

4 recalls that day

South Texas Blood & Tissue Center Pooled Platelets and Red Blood Cells

Red blood cells and pooled platelets were collected from a donor who was a resident of a malaria endemic area.

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

Eversight Illinois Cornea

The cornea was distributed without ensuring the donor was free from risk factors for and clinical evidence of relevant communicable disease agents and diseases.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 100008

Eversight Illinois Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 100007

Eversight Illinois 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 100006

3 recalls that day

Central California Blood Center Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex were distributed from a donor not re-entered appropriately after Chagas testing.

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

Oklahoma Lions Eye Bank 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

Eversight Cornea

Corneas were distributed from a donor who failed eligibility determination for infection risk.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99988

3 recalls that day

Saving Sight Cornea

Corneas were distributed without appropriate donor screening tests, risking transmission of communicable diseases.

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

VisionGift Cornea

The cornea was distributed without ensuring the donor was free from risk factors for and clinical evidence of relevant communicable disease agents and diseases.

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

Eversight Illinois 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 99974

1 recall that day

HCSC-Blood Center Plasma and Red Blood Cells

HCSC-Blood Center Plasma and Red Blood Cells, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99048

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, FDA event number 99047

7 recalls that day

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

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

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

14 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

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

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, FDA event number 99917

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

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

3 recalls that day

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

1 recall that day

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

1 recall that day

Suncoast Communities Blood Bank Red Blood Cells and Whole Blood

Suncoast Communities Blood Bank Red Blood Cells and Whole Blood, collected from donors for whom donor eligibility screening was incomplete, were distributed.

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

1 recall that day

OneBlood Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a therapeutic donor incorrectly registered as allogeneic.

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

3 recalls that day

New York Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor previously deferred for hepatitis C virus antibody testing.

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

Hoxworth Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99471

Walter L. Shepeard Community Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

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

2 recalls that day

LifeShare Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed after incomplete donor eligibility screening.

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

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99418

2 recalls that day

Hoxworth Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99417

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor in a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99416

2 recalls that day

Suncoast Communities Blood Bank Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had recently traveled to a malaria endemic area.

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

Blood Assurance Pooled Cryoprecipitated AHF and Red Blood Cells

Red Blood Cells and Pooled Cryoprecipitated AHF were collected from a donor at increased risk for Creutzfeldt-Jakob Disease.

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