BEUDAMED
    FDA Enforcement Class II Terminated

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    Recall: Z-2159-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2159-2019
    Event ID
    83183
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DRG Instruments GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2019
    Initiation Date
    May 21, 2019
    Classification Date
    August 5, 2019
    Termination Date
    May 29, 2020
    Address
    Frauenbergstr. 18, N/A, Marburg, N/A, N/A, Germany

    Description

    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    Reason

    Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower

    Code Info

    Lot Numbers: 66K118, 66K019

    Distribution

    Worldwide Distribution - US Nationwide CA, MI Foreign: Canada, Brazil, China, Poland

    Quantity

    38 kits