BEUDAMED
    FDA Recall Terminated

    Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20

    Recall: Z-0722-2007 · Initiated January 30, 2007

    Recall

    Recall Number
    Z-0722-2007
    Event Number
    37334
    Firm
    Abbott Laboratories Inc.
    FEI Number
    2018433
    Product Code
    CEO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 30, 2007
    Posted
    April 5, 2007
    Terminated
    August 10, 2011
    Address
    820 Mission St, South Pasadena, CA, 91030-3142

    Description

    Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and 7D71-20

    Reason

    Patient results are falsely decreased by up to 15% at these levels: 1) Serum Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus greater than 80.0 mg/dL (25.80 mmol/L)

    Action

    A Product Correction letter dated January 30, 2007 provided to all Clinical Chemistry Phosphorus customers that have received lot numbers 42020HW00 and 44037HW00 stating that patient results are falsely decreased by up to 15% at these levels: Serum/Plasma phosphorus greater than 8.0 mgldL (2.60 mmol/L) and Urine phosphorus greater than 80.0 mg/dl. (25.80 mmol/L). Modified linearity ranges are provided in the letter that are to be implemented when using the two lots. Instructions are also provided for changing the linearity range on the Architect cSystem as well as the Aeroset System. Customers are instructed that If they have forwarded any of Information the Clinical Chemistry Phosphorus lots listed above to another laboratory to provide a copy of this letter to them. A customer response form is provided.

    Distribution

    Worldwide, including USA, Canada, Trinidad & Tobago, Bahamas, Panama, Cayman Islands, Jamaica

    Quantity

    42020HW00 - 1,351 units worldwide; 44037HW00 - 314 units worldwide