FDA recall, , Moderate risk
American National Red Cross Apheresis Platelets, PAS, Leukocytes Reduced
Apheresis Platelets, PAS, Leukocytes Reduced were distributed without quality control testing.
Recall ended Aug 4, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
American Natl. Red Cross-Greater Chesapeake & Potomac Region began a recall of Apheresis Platelets, PAS, Leukocytes Reduced on September 4, 2025, because the product was collected on an instrument undergoing equipment qualification and for which quality control testing was not performed. The FDA added the recall to its Enforcement Report on August 4, 2026, and it was listed in the weekly enforcement report on August 12, 2026. The recall involves product distributed in Maryland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare these details with yours, then check the recall notice to see which units are recalled.
Apheresis Platelets, PAS, Leukocytes Reduced
Recall details
- Company began the recall
- Sold in
- Company
- American Natl. Red Cross-Greater Chesapeake & Potomac Region
- Hazard
- Quality testing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99395
- Recall number
- B-0168-2026
All recalls from American Natl. Red Cross-Greater Chesapeake & Potomac Region
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA · Recall ended
In FDA's weekly enforcement report
Listed on Recall Canary
