BEUDAMED
    FDA Enforcement Class II Terminated

    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

    Recall: Z-1613-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1613-2013
    Event ID
    65377
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 28, 2013
    Classification Date
    June 27, 2013
    Termination Date
    June 3, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232, United States

    Description

    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).

    Reason

    Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with error condition OCR LOW. The calibration failures appear to be related to improper shipping or storage conditions (frozen reagent). Failed calibration of LACT may cause a delay in reporting results.

    Code Info

    Part Number A95550, Lot Number M210077

    Distribution

    Worldwide Distribution - USA Nationwide and country of Canada.

    Quantity

    3,353 units