BEUDAMED
    FDA Recall Completed

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

    Recall: Z-2115-2025 · Initiated February 27, 2025

    Recall

    Recall Number
    Z-2115-2025
    Event Number
    97018
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    CDD
    Status
    Completed
    Root Cause
    Process control
    Initiated
    February 27, 2025
    Posted
    July 11, 2025
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    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.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated 2/19/25 was sent to customers. ACTION: Discontinue using Access Vitamin B12 reagent lot 439850. Discard all remaining reagent packs from this lot following your laboratory procedures. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient results. Contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com You may request replacement product by contacting your local Beckman Coulter Representative for replacement.

    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