Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Pending LLM rewrite. Source: FDA_DEVICE Z-2115-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Manufacturer
- Beckman Coulter, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 15099590224301
- Lot Number: 439850
Distribution
Distribution scope not specified by the agency.
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