BEUDAMED
    FDA Recall Terminated

    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

    Recall: Z-1140-03 · Initiated July 21, 2003

    Recall

    Recall Number
    Z-1140-03
    Event Number
    26856
    Firm
    Perkinelmer Life Sciences, Inc.
    FEI Number
    1000513616
    Product Code
    DHN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2003
    Posted
    August 20, 2003
    Terminated
    November 19, 2003
    Address
    549 Albany Street, Boston, MA, 02118

    Description

    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

    Reason

    Product's outer carton label was labeled with an extended expiration date

    Action

    PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned.

    Distribution

    CA, PA, IN, MO Foreign: Switzerland

    Quantity

    69 kits