BEUDAMED
    FDA Recall Terminated

    Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 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-1400-2013 · Initiated April 17, 2013

    Recall

    Recall Number
    Z-1400-2013
    Event Number
    63367
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KHP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 17, 2013
    Posted
    May 24, 2013
    Terminated
    October 22, 2014
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 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 initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.

    Action

    Beckman Coulter sent an Urgent Product Correction letter dated April 17, 2013 to all affected customers. The letter identified the affected product, problem actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter Customer Support Center (Call Center) on the Beckman Website at http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada.

    Distribution

    Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom

    Quantity

    8,774 units