Recall Z-2115-2025— Beckman Coulter, Inc.

Name: FDA recall Z-2115-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-27

Class II · Completed

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-02-27. It names one FDA 510(k) clearance: K955436. Product: Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850. Reason: 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..

Recalling firm: Beckman Coulter, Inc.
Classification: Class II
Status: Completed
Initiated: 2025-02-27
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K955436 — ACCESS VITAMIN B12 ASSAY (MODIFICATION)Bio-Rad Laboratories, Inc.·cleared 1996-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.