BEUDAMED
    FDA Recall Terminated

    ABL800 analyzer, model numbers 393-800 and 393-801.

    Recall: Z-0682-2019 · Initiated July 3, 2018

    Recall

    Recall Number
    Z-0682-2019
    Event Number
    81547
    Firm
    Radiometer America Inc
    FEI Number
    3010420736
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 3, 2018
    Terminated
    August 30, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    ABL800 analyzer, model numbers 393-800 and 393-801.

    Reason

    The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

    Action

    The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx.

    Distribution

    Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.

    Quantity

    2,131 analyzers