BEUDAMED
    FDA Recall Terminated

    Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.

    Recall: Z-2328-2009 · Initiated April 22, 2009

    Recall

    Recall Number
    Z-2328-2009
    Event Number
    51872
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 22, 2009
    Posted
    September 30, 2009
    Terminated
    February 25, 2010
    Address
    104 Windsor Center Dr, East Windsor, NJ, 08520

    Description

    Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.

    Reason

    It appears that the rechargeable battery pack is overheating with or without the presence of smoke.

    Action

    Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.

    Distribution

    Worldwide Distribution

    Quantity

    2552