FDA recall, , Moderate risk
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.
Versiti Michigan began this recall on Dec 29, 2023. FDA posted it on Nov 2, 2026, the day the recall ended.
Summary by Recall Canary from the FDA notice
What happened
Versiti Michigan Inc, based in Grand Rapids, Michigan, voluntarily initiated a firm-initiated recall of Red Blood Cells, Leukocytes Reduced. The recall was due to Whole Blood collection using a scale that did not undergo daily quality control, and the quarantined product was distributed prior to the completion of the investigation.
The recall began on December 29, 2023, and was added to the FDA's Enforcement Report on November 2, 2026. Customers were notified by FAX. The recall involved product distributed in Michigan.
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.
Red Blood Cells, Leukocytes Reduced
- Unit number
- W120623130488
Recall details
- Posted by FDA
- Recall began
- Status
- Ended Nov 2, 2026
- Weekly archive
- Listed the week of Nov 2, 2026
- Distributed to
- Recalled by
- Versiti Michigan IncGrand Rapids, Michigan
- 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
- 100021
- Recall number
- B-0032-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- FAX
All recalls from Versiti Michigan Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Versiti Michigan began the recall
FDA posted the recall to its Enforcement Report, rated it Class II (moderate risk) and closed it
Added to Recall Canary
