BEUDAMED
    FDA Recall Terminated

    Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.

    Recall: Z-0898-03 · Initiated January 8, 2003

    Recall

    Recall Number
    Z-0898-03
    Event Number
    26138
    Firm
    PerkinElmer LIfe Sciences Inc
    FEI Number
    1522510
    Product Code
    JJT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 8, 2003
    Posted
    May 29, 2003
    Terminated
    September 13, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203

    Description

    Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.

    Reason

    The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

    Action

    The firm notified their customers by letter on 1/8/2003.

    Distribution

    The kits were shipped to three (3) State Departments of Health in WI, AR, and MI.

    Quantity

    75 Kits