BEUDAMED
    FDA Recall Terminated

    Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.

    Recall: Z-1139-03 · Initiated June 27, 2003

    Recall

    Recall Number
    Z-1139-03
    Event Number
    26606
    Firm
    PerkinElmer Life Sciences Inc
    FEI Number
    1522510
    Product Code
    JLJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2003
    Posted
    August 20, 2003
    Terminated
    October 24, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203

    Description

    Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.

    Reason

    The kits are producing lower values than expected, which may result in an increase of false positive test results.

    Action

    The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.

    Distribution

    The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.

    Quantity

    85 kits