BEUDAMED
    FDA Recall Terminated

    Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000

    Recall: Z-0515-04 · Initiated January 9, 2004

    Recall

    Recall Number
    Z-0515-04
    Event Number
    28087
    Firm
    Perkin Elmer Life and Analytical Sciences Inc
    FEI Number
    1522510
    Product Code
    JIA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 9, 2004
    Posted
    July 20, 2004
    Terminated
    October 29, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203-6215

    Description

    Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000

    Reason

    The device is not stable throughout its labeled expiration date.

    Action

    The firm contacted their customers by letter on 1/9/2004.

    Distribution

    The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.

    Quantity

    178 kits