BEUDAMED
    FDA Enforcement Class II Terminated

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    Recall: Z-2836-2018 · Reported August 22, 2018

    Enforcement

    Recall Number
    Z-2836-2018
    Event ID
    80575
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DRG Instruments GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2018
    Initiation Date
    July 14, 2016
    Classification Date
    August 16, 2018
    Termination Date
    August 4, 2020
    Address
    Frauenbergstr. 18, Marburg, N/A, Germany

    Description

    Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.

    Reason

    Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.

    Code Info

    Lot # 68K056 Exp. Date 2017-05

    Distribution

    NJ; Germany, Belgium, Spain & Germany

    Quantity

    169 kits