FDA recall Z-2115-2025

Beckman Coulter, Inc. · Class II · device

Product

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.

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

Key facts

Status: Completed
Initiation date: 2025-02-27
Report date: 2025-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2115-2025