BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-2115-2025 · Reported July 23, 2025

    Enforcement

    Recall Number
    Z-2115-2025
    Event ID
    97018
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2025
    Initiation Date
    February 27, 2025
    Classification Date
    July 11, 2025
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    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.

    Code Info

    UDI-DI: 15099590224301; Lot Number: 439850

    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

    Quantity

    10,000 units