BEUDAMED
    FDA Recall Terminated

    AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum

    Recall: Z-0172-2009 · Initiated August 25, 2008

    Recall

    Recall Number
    Z-0172-2009
    Event Number
    49131
    Firm
    Pointe Scientific, Inc.
    FEI Number
    1827821
    Product Code
    CIT
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 25, 2008
    Posted
    October 22, 2008
    Terminated
    November 27, 2009
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum

    Reason

    The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.

    Action

    Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance.

    Distribution

    Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia.

    Quantity

    25 vials