BEUDAMED
    FDA Recall Terminated

    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

    Recall: Z-0779-2017 · Initiated November 16, 2016

    Recall

    Recall Number
    Z-0779-2017
    Event Number
    75708
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3006159931
    Product Code
    CGJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 16, 2016
    Posted
    December 16, 2016
    Terminated
    July 5, 2017
    Address
    940 Winter St, Waltham, MA, 02451-1457

    Description

    DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

    Reason

    A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.

    Action

    PerkinElmer initiated recall on November 16, 2016, delivered to the end customer by email facilitated through the PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and understand the recommended actions. Users asked to inspect inventory, discontinue use destroy the kits and complete the Response Forms and Destruction.Replacement kits will shipped.

    Distribution

    CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,

    Quantity

    79 kits