BEUDAMED
    FDA Enforcement Class II Terminated

    Beckman Coulter Lipase, REF OSR6130 and OSR6230.

    Recall: Z-0210-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0210-2020
    Event ID
    83583
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    August 24, 2018
    Classification Date
    October 24, 2019
    Termination Date
    August 2, 2024
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    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.

    Code Info

    All lots

    Distribution

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

    Quantity

    20,926 units