Access Vitamin B12 Reagent — Class II medical device recall Z-2115-2025
Completed recall by Beckman Coulter, Inc., reported 2025-07-23. Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent
| Recall number | Z-2115-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-02-27 |
| Classified | 2025-07-11 |
| Reported by FDA | 2025-07-23 |
| Countries outside the US | BG, CH, DE, DK, EE, ES, FR, GB, GR, IE, IT, NL, PT, RO, TR |
| Quantity | 10,000 units |
| UPC / GTIN / UDI-DI | 15099590224301 |
| Lot numbers | 439850 |
| Model numbers | 33000 |
Product
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2115-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.