BEUDAMED
    FDA Recall Terminated

    ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27

    Recall: Z-0705-2007 · Initiated January 16, 2007

    Recall

    Recall Number
    Z-0705-2007
    Event Number
    37167
    Firm
    Radiometer America Inc
    FEI Number
    1523456
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 16, 2007
    Posted
    April 6, 2007
    Terminated
    May 8, 2012
    Address
    810 Sharon Dr, Westlake, OH, 44145-1598

    Description

    ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27

    Reason

    In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.

    Action

    Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.

    Distribution

    Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark

    Quantity

    64 in U.S. & 1,281 to foreign accounts