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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).Browse by hazard

Antibody drugs and other therapeutic biologics that FDA regulates as drugs are listed under Drugs, as FDA files them.

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2 recalls that day

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100028

American National Red Cross Apheresis Platelets

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

Moderate risk, FDA, Ended, Hospital use, Processing problem, FDA event number 100027

4 recalls 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

ImpactLife Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced lack documentation of acceptable storage temperature and agitation.

Moderate risk, FDA, Ended, Hospital use

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for residual white blood cells or red blood cells after an RBC spillover.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100025

American Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced lack documentation of return to acceptable storage temperature.

Moderate risk, FDA, Ended, Hospital use

1 recall that day

Versiti Michigan Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were quarantined due to a scale that lacked daily quality control, and were distributed before investigation completion.

Moderate risk, FDA, Ended, Hospital use

2 recalls that day

Greer Laboratories Sterile Diluent for Allergenic Extracts Normal Saline

Retention samples from this lot exhibited evidence of glass delamination.

Low risk, FDA, Clinic use

Greer Laboratories Sweet Vernal Grass Pollen

The product has a phenol concentration above the specification limit.

Low risk, FDA, Clinic use

1 recall that day

Greer Laboratories Sterile Diluent for Allergenic Extract

Sterile Diluent for Allergenic Extract, Normal Saline has a lower than expected phenol level.

Low risk, FDA, Clinic use, Quality testing problem

3 recalls that day

American Red Cross Blood Svcs Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced may have exceeded the acceptable collection volume.

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

We Are Blood Pooled Platelets, Leukocytes Reduced, Irradiated

Pooled Platelets, Leukocytes Reduced, Irradiated were not tested for pH.

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

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, FDA event number 99793

2 recalls that day

Biomedical Data Solutions Ortho Connect Software

Ortho Connect software can incorrectly reject potential discrepant results during result review.

Moderate risk, FDA, Ended, Software defect

ARUP Laboratories Apheresis Platelets, PAS, Leukocytes Reduced

The platelets were labeled as leukocytes reduced but were not tested to verify residual white blood cell count, and pH testing was not performed.

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

1 recall that day

Diagnostic Grifols Erytra Analyzer

The Erytra analyzer can assign incorrect results for an autocancelled and rescheduled test, potentially leading to an incident if a transfusion is performed.

Moderate risk, FDA, Ended, Software defect

1 recall that day

Diagnostic Grifols Erytra and Erytra Eflexis Automated Blood Grouping and Antibody Test Systems

An issue in how these blood grouping systems titrate antibodies can cause minor variations in titration results.

Low risk, FDA, Ended, Device defect

2 recalls that day

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet yield.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 100018

South Texas Blood & Tissue Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

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

1 recall that day

American National Red Cross Apheresis Platelets

Apheresis Platelets lacked documentation of time exposed to the Compound Absorption Device during pathogen reduction.

Low risk, FDA, Ended, Hospital use, Contamination, FDA event number 99819

10 recalls that day

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

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

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

American National Red Cross Red Blood Cells Leukocytes Reduced Irradiated

The product was misbranded.

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

American National 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 antigen positive.

Moderate risk, FDA, Ended, Hospital use, Labeling error, FDA event number 99789

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

American National Red Cross Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced were distributed with a misbranding issue.

Moderate risk, FDA, Ended, Hospital use, Mislabeled product, FDA event number 99788

Department of Defense - Army Blood Components

Red Blood Cells, Whole Blood, Liquid Plasma, Fresh Frozen Plasma, and Red Blood Cells, Leukocytes Reduced may have been prepared with incorrect arm preparation.

Moderate risk, FDA, Ended, Hospital use

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

American National Red Cross Apheresis Red Blood Cells

The product was misbranded.

Moderate risk, FDA, Ended, Hospital use, Mislabeled product, FDA event number 99740

Versiti Illinois Apheresis Platelets, Leukocytes Reduced

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

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

10 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

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The product did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99170

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99169

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99168

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99167

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99166

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99165

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

The product did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99164

6 recalls that day

New York Blood Center Apheresis Platelets, Leukocytes Reduced

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

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

Blood Assurance Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without a tag indicating they contained antibodies.

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

West TN Regional Blood Center Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for pH.

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

LifeStream Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

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

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated were labeled as leukocytes reduced but were not tested to verify white blood cell count.

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

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