BEUDAMED
    FDA Enforcement Class II Terminated

    ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter

    Recall: Z-0231-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0231-2018
    Event ID
    78445
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    October 24, 2017
    Classification Date
    December 8, 2017
    Termination Date
    October 10, 2023
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter

    Reason

    Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

    Code Info

    All serial numbers

    Distribution

    USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.

    Quantity

    1,749 analyzers