FDA Device recall Z-2115-2025
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- FDA Device
- Class II
- completed
- Published 2025-07-23
On 2025-07-23 the FDA classified a Class II recall of Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 by Beckman Coulter, citing 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 hi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2115-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-02-27 |
| Published | 2025-07-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
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.
Identifiers
| code_info | UDI-DI: 15099590224301; Lot Number: 439850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2115-2025%22
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