BEUDAMED
    FDA Recall Terminated

    ST AIA-PACK PROG III, Progesterone III Assay, Part Number: 025240

    Recall: Z-0826-2018 · Initiated February 13, 2018

    Recall

    Recall Number
    Z-0826-2018
    Event Number
    79176
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    JLS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 13, 2018
    Terminated
    October 29, 2020
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    Description

    ST AIA-PACK PROG III, Progesterone III Assay, Part Number: 025240

    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.

    Action

    The assays identified in the above table must not be used to report results for patients who are taking DHEA supplements. " For patients that are taking DHEA supplements, an alternative testing method which is not expected to show cross reactivity to DHEA-S should be used such as Liquid Chromatography-Mass Spectroscopy (LCMS). " Please review the information in this Urgent Medical Device Recall with your Medical Director and/or Lab Director, as soon as possible. " Continue to use the Progesterone Assays for patients who are not receiving DHEA supplements or therapy. " Complete and return the attached Urgent Medical Device Recall Acknowledgement Form within 15-days. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at 1(800) 248-6764 or email [email protected]. " Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at 1(800) 248-6764, or by email at [email protected]. We will be available to answer any questions Monday - Friday, from 8:00 AM to 5:00 PM (PST).

    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

    3322