BEUDAMED
    FDA Recall 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 · Initiated May 21, 2019

    Recall

    Recall Number
    Z-2159-2019
    Event Number
    83183
    Firm
    DRG Instruments GmbH Frauenbergstr. 18 Marburg Germany
    FEI Number
    3002800697
    Product Code
    CDZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 21, 2019
    Terminated
    May 29, 2020

    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

    Action

    DRG International issued notification via email on 5/21/19 advising of the problem, health risk and action to take: 1. We kindly ask you to immediately examine your stock and promptly quarantine these products, 2. Please send back or discard all unused kits. 3. Please use the attached response form, fill, sign and send back to us.4. Please inform your customers and forward this letter and notice to persons who received the affected lots and request they fill out the form and return at once.5. Patient samples that have been determined with the affected lots should be checked again carefully. If results are lower than expected samples should be re-run again. 6. Please tell us if you have experienced any problem with this lot and specify the details. Reply to DRG (email: [email protected] and copy [email protected]).

    Distribution

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

    Quantity

    38 kits