BEUDAMED
    FDA Enforcement Class II Terminated

    ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

    Recall: Z-0825-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0825-2018
    Event ID
    79176
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tosoh Bioscience Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    February 13, 2018
    Classification Date
    March 1, 2018
    Termination Date
    October 29, 2020
    Address
    3600 Gantz Rd, N/A, Grove City, OH, 43123-1895, United States

    Description

    ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239

    Reason

    Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.

    Code Info

    All lots

    Distribution

    Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

    Quantity

    5579