BEUDAMED
    FDA Recall Terminated

    i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.

    Recall: Z-0812-2010 · Initiated September 9, 2009

    Recall

    Recall Number
    Z-0812-2010
    Event Number
    53335
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 9, 2009
    Posted
    February 24, 2010
    Terminated
    December 8, 2014
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.

    Reason

    The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.

    Action

    An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.

    Distribution

    Worldwide Distribution (including the United States).

    Quantity

    3,918 analyzers