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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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4 recalls that day

LifeShare Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who lacked documentation of arm inspection.

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

Bloodworks Platelets Extended Dating

Platelets Extended Dating were distributed without a visual inspection.

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

1 recall that day

American Red Cross Blood Services Blood Components

Red blood cells, plasma, and cryoprecipitated AHF may have been prepared with incorrect arm preparation.

Moderate risk, FDA, Ended, Hospital use

2 recalls that day

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

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

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

ImpactLife PF24RT24 Plasma

PF24RT24 Plasma was distributed after incomplete donor eligibility screening.

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

1 recall that day

American National Red Cross Cryoprecipitated AHF

American National Red Cross Cryoprecipitated AHF, that failed to meet the minimum specifications for fibrinogen levels, were distributed.

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

1 recall that day

Blood Bank of Hawaii Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis 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

3 recalls that day

ALBA Bioscience ALBAzyme Papain Solution Kit

ALBAzyme Papain Solution Kit may have reduced activity, causing incomplete removal of enzyme-sensitive antigens from red blood cells.

Low risk, FDA, Ended, Device defect

ALBA Bioscience Ortho Sera Papain

ORTHO Sera Papain has reduced reactivity, which may cause hemolytic transfusion reactions.

Low risk, FDA, Ended, Device defect

Terumo BCT Rika Plasma Donation System

The Rika Plasma Donation System has a potential safety issue with an electrical component in its control valve.

Moderate risk, FDA, Ended, Device defect

1 recall that day

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed without a visual inspection.

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

2 recalls that day

Thermo Fisher Scientific TSCM17, TSCM34 and TSCM48 Laboratory Freezers

The CryoMed Controlled-Rate Freezer may have a heater that can trip a circuit breaker or shock the user.

Moderate risk, FDA, Ended, Device defect

American National Red Cross Cryoprecipitated AHF and Blood Components

Blood products including Cryoprecipitated AHF, PF24 Plasma, and Red Blood Cells may have been prepared with incorrect arm preparation.

Moderate risk, FDA, Ended, Hospital use

1 recall that day

Ortho-Clinical Diagnostics ORTHO VISION and ORTHO VISION Max Analyzers

Ortho Vision Analyzers and Ortho Vision Max Analyzers have a software anomaly that can cause incorrect association of samples and erroneous patient results.

Moderate risk, FDA, Ended, Software defect

2 recalls that day

Biomedical Data Solutions Complete Ortho Connect 3.x Software

Complete Ortho Connect 3.x Software has an issue with check rules that could lead to an incorrect result.

Moderate risk, FDA, Ended, Software defect

WellSky Transfusion Blood-Bank Management System

The WellSky Transfusion standalone blood-bank management system can fail to present a required soft-stop alert.

Moderate risk, FDA, Ended, Software defect

1 recall that day

American National Red Cross Blood Components

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

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

2 recalls that day

New York Blood Center Apheresis Platelets, Leukocytes Reduced

The platelets were distributed with platelet yield that did not meet specifications.

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

Community Blood Center of Greater Kansas City Apheresis Red Blood Cells

Leukoreduced Apheresis Red Blood Cells products, collected from a donor whose health history screening was not adequately performed, were distributed.

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

1 recall that day

American Red Cross Norfolk Main Site Apheresis Platelets and Red Blood Cells

American Red Cross Norfolk Main Site cells, for which Babesia testing was not performed, were distributed.

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

1 recall that day

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

American National Red Cross - Johnstown, PA products, for which Babesia testing was not performed, were distributed.

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

1 recall that day

American National Red Cross Red Blood Cells

American National Red Cross Red Blood Cells, for which Babesia testing was not performed, were distributed.

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