FDA recall, , Moderate risk
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.
American National Red Cross began this recall on Oct 8, 2025. FDA posted it on Nov 3, 2026, the day the recall ended.
Summary by Recall Canary from the FDA notice
What happened
The American National Red Cross, based in Columbus, Ohio, voluntarily initiated a recall of Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced on October 8, 2025, because the product was not tested for residual white blood cells or red blood cells after an RBC spillover during apheresis collection. The recall was added to the FDA's Enforcement Report on November 3, 2026, and customers were notified by telephone. The affected product was distributed in Michigan and Ohio.
What to do
Biologics such as blood, tissue and vaccines are usually given by hospitals and clinics. If you had a transfusion, transplant, infusion or vaccine, ask the place that treated you whether this product was used. If they contact you, follow their advice.
What was recalled
Hospitals, clinics and blood banks match these details against their records.
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced
- Unit number
- W18162584411100B
Recall details
- Posted by FDA
- Recall began
- Status
- Ended Nov 3, 2026
- Weekly archive
- Listed the week of Nov 2, 2026
- Recalled by
- American National Red CrossColumbus, Ohio
- Hazard
- Quality testing problem
- Risk
Moderate risk
Its use may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100025
- Recall number
- B-0034-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Telephone
All recalls from American National Red Cross
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
American National Red Cross began the recall
FDA posted the recall to its Enforcement Report, rated it Class II (moderate risk) and closed it
Added to Recall Canary