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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.

FDA Recall Z-0968-2010 · Posted 2010-03-03

Recalling FirmQuest Products Inc.
Recall StatusTerminated
Product CodeNGE
Date Initiated2008-11-07
Date Terminated2010-03-03
Product Quantity3,930 cases

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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