BEUDAMED
    FDA Recall Terminated

    Beckman Coulter Lipase, REF OSR6130 and OSR6230.

    Recall: Z-0210-2020 · Initiated August 24, 2018

    Recall

    Recall Number
    Z-0210-2020
    Event Number
    83583
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CDT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 24, 2018
    Terminated
    August 2, 2024
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Beckman Coulter Lipase, REF OSR6130 and OSR6230.

    Reason

    NAPQI, a metabolite of Acetaminophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients.

    Action

    The recalling firm issued letters dated 8/21/2018 via email or postal mail if an email address was not available on 8/24/2018 to their customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-223-0139 in the United States and Canada. Outside the United States and Canada contact local Beckman Coulter Representative.

    Distribution

    Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada.

    Quantity

    20,926 units