BEUDAMED
    FDA Recall Terminated

    Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.

    Recall: Z-0971-03 · Initiated May 30, 2003

    Recall

    Recall Number
    Z-0971-03
    Event Number
    26412
    Firm
    PerkinElmer Life Sciences Inc
    FEI Number
    1522510
    Product Code
    JIA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 30, 2003
    Posted
    July 2, 2003
    Terminated
    October 24, 2008
    Address
    3985 Eastern Rd, Norton, OH, 44203

    Description

    Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.

    Reason

    The device is not stable throughout its labeled expiration date.

    Action

    The firm contacted their customers by telephone and facsimile on 5/30/2003.

    Distribution

    Nationwide. The product was also shipped to foreign distributors and end-users located in Brazil, Costa Rica, Mexico, Finland, Venezuela, Taiwan, and Korea.

    Quantity

    42 kits