BEUDAMED
    FDA Recall Terminated

    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.

    Recall: Z-1499-04 · Initiated September 8, 2004

    Recall

    Recall Number
    Z-1499-04
    Event Number
    29979
    Firm
    PerkinElmer LAS Inc
    FEI Number
    1522510
    Product Code
    JIA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 8, 2004
    Posted
    September 30, 2004
    Terminated
    October 29, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203-6215

    Description

    Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.

    Reason

    There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the specified range.

    Action

    The firm contacted their consignees by letter sent 9/8/04.

    Distribution

    The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.

    Quantity

    49 kits