Reported Jul 23, 2025 · Completed
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
Access Vitamin B12 ReagentCatalog Number 33000Lot Number 439850
- Lot codes and dates
- UDI-DI15099590224301
- Lot Number439850
- Amount recalled
- 10,000 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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