Recall archive / FDA device enforcement
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 — FDA record Z-2115-2025
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Reason
- Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
- Classification
- Class II
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 10,000 units
- Agency-reported status
- Completed
- Source record identifier
- Z-2115-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 15099590224301; Lot Number: 439850 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 23, 2025
- Recall initiation date
- Feb 27, 2025
- Center classification date
- Jul 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.