BEUDAMED
    FDA Recall Terminated

    OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator for the qualitative changes (ferning) of salt content in saliva to aid in the prediction of ovulation; Distributed by Quest Products, Libertyville, IL A rapid saliva indicator for the qualitative prediction of favorable and unfavorable fertile days in women's menstrual cycles.

    Recall: Z-0968-2010 · Initiated November 7, 2008

    Recall

    Recall Number
    Z-0968-2010
    Event Number
    52901
    Firm
    Quest Products Inc.
    FEI Number
    3005857009
    Product Code
    NGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2008
    Posted
    March 3, 2010
    Terminated
    March 3, 2010
    Address
    14052 W Petronella Dr, Ste 103, Libertyville, IL, 60048-9512

    Description

    OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator for the qualitative changes (ferning) of salt content in saliva to aid in the prediction of ovulation; Distributed by Quest Products, Libertyville, IL A rapid saliva indicator for the qualitative prediction of favorable and unfavorable fertile days in women's menstrual cycles.

    Reason

    The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.

    Action

    Quest Products notified their major customer by telephone and e-mail on 11/7/08, requesting the return of all inventory of the OvuChek Saliva Ovulation Test Strips due to a lack of 510(k) clearance for marketing of the device.

    Distribution

    Nationwide

    Quantity

    3,930 cases