Beckman Coulter, Inc. recalls Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Recall date

February 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2115-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850