BEUDAMED
    FDA Recall 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 · Initiated May 28, 2013

    Recall

    Recall Number
    Z-1613-2013
    Event Number
    65377
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KHP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 28, 2013
    Posted
    June 27, 2013
    Terminated
    June 3, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    Beckman Coulter Inc. sent an Urgent Product Correction letter dated May 28, 2013 to affected customers. The letter identified the affected product, the issue, impact, actions to be taken, and resolution. The letter instructed customers to discontinue use of the affected product and request a replacement product. For questions contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call 800-854-3633 in the United States and Canada. Outside the United States or Canada, contact your local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution - USA Nationwide and country of Canada.

    Quantity

    3,353 units