Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Access Vitamin B12 Reagent Recalled by Beckman Coulter, Inc. Due to Beckman Coulter has received complaints of erroneous Vitamin...

Date: February 27, 2025
Company: Beckman Coulter, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.

Affected Products

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

Quantity: 10,000 units

Why Was This 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.

Where Was This Sold?

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

About Beckman Coulter, Inc.

Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report