Beckman Coulter, Inc. — Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- February 27, 2025
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
What's affected?
- Product
- Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
- Lot code
- 439850
Additional details
UDI-DI: 15099590224301; Lot Number: 439850
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10,000 units.
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