BEUDAMED
    FDA Recall Terminated

    IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent

    Recall: Z-0894-05 · Initiated March 24, 2005

    Recall

    Recall Number
    Z-0894-05
    Event Number
    31592
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    JHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2005
    Posted
    June 16, 2005
    Terminated
    September 29, 2005
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent

    Reason

    Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.

    Action

    Abbot Health Products, Inc informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.

    Distribution

    US Goverment, Domestic and International distribution.

    Quantity

    793 kits