BEUDAMED
    FDA Recall Terminated

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

    Recall: Z-1976-2012 · Initiated September 8, 2011

    Recall

    Recall Number
    Z-1976-2012
    Event Number
    62319
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 8, 2011
    Posted
    July 9, 2012
    Terminated
    January 28, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

    Reason

    Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

    Action

    Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    6000-0000-650 units