BEUDAMED
    FDA Enforcement Class II Terminated

    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

    Recall: Z-2410-2019 · Reported September 4, 2019

    Enforcement

    Recall Number
    Z-2410-2019
    Event ID
    83177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DRG Instruments GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 4, 2019
    Initiation Date
    June 6, 2019
    Classification Date
    August 27, 2019
    Termination Date
    May 11, 2020
    Address
    Frauenbergstr. 18, N/A, Marburg, N/A, N/A, Germany

    Description

    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic

    Reason

    Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result.

    Code Info

    Lot Number:315K029

    Distribution

    Distribution to Canada

    Quantity

    8 Kits