FDA recall, , Low risk
ALBA Bioscience ALBAzyme Papain Solution Kit
The ALBAzyme Papain Solution Kit has reduced activity that may cause incomplete removal of enzyme-sensitive antigens.
Recall ended Jul 23, 2026. Still check yours.
Summary by Recall Canary from the FDA notice
What happened
ALBA Bioscience Limited is recalling its ALBAzyme Papain Solution Kit, Part No. Z317U, due to reduced activity that may result in incomplete removal of enzyme-sensitive antigens from the red blood cell surface and/or reduced enhancement of other specificities. The recall began on July 3, 2025, and was added to the FDA's Enforcement Report on May 5, 2026. The product was distributed in California, Georgia, Indiana, Kansas, Louisiana, Texas, Virginia, Vermont and Wyoming.
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 your kit affected?
Match the list below, then check the codes the FDA notice also names.
ALBAzyme Papain Solution Kit
- Lot code
- V278995
From the FDA notice
ALBAzyme Papain Solution Kit, Part No. Z317U, UDI 05060242471223
Recall details
- Company began the recall
- Company
- ALBA Bioscience Limited
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 97231
- Recall number
- B-0050-2026
All recalls from ALBA Bioscience Limited
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
In FDA's weekly enforcement report
Recall ended
Listed on Recall Canary
Archived
