BEUDAMED
    FDA Enforcement Class III Terminated

    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.

    Recall: Z-2282-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2282-2016
    Event ID
    74452
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    June 7, 2016
    Classification Date
    July 25, 2016
    Termination Date
    February 22, 2017
    Address
    6000 Shoreline Ct Ste 101, N/A, South San Francisco, CA, 94080-7606, United States

    Description

    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.

    Reason

    Instructions For Use had incorrect lot number and calibrator values

    Code Info

    Catalog Number 02534001 (One set of Calibrators US) Lot G13C303 (only those received/repackaged in the US)

    Distribution

    US Nationwide Distribution in the states of AL; CA; CO; FL; KY; MA; NY; OH; SC; TX; UT; VA and WI.

    Quantity

    41 single sets of Progesterone 3 calibrators