BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-0779-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0779-2017
    Event ID
    75708
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    November 16, 2016
    Classification Date
    December 16, 2016
    Termination Date
    July 5, 2017
    Address
    940 Winter St, N/A, Waltham, MA, 02451-1457, United States

    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.

    Code Info

    Lot Number: 646091

    Distribution

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

    Quantity

    79 kits