Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2115-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 27, 2025

Date Posted: July 23, 2025

Recall Number: Z-2115-2025

Event ID: 97018

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.

Status: Ongoing

Product Quantity: 10,000 units

Code Information:

UDI-DI: 15099590224301; Lot Number: 439850

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated