Medical Device Recall: Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Beckman Coulter, Inc. · February 27, 2025
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.
Distribution
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
Quantity Affected
10,000 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2115-2025
Status: completed
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.