BEUDAMED
    FDA Recall 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 · Initiated October 24, 2017

    Recall

    Recall Number
    Z-0231-2018
    Event Number
    78445
    Firm
    Radiometer America Inc
    FEI Number
    3010420736
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software in the Use Environment
    Initiated
    October 24, 2017
    Terminated
    October 10, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    Action

    Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.

    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