Z-0968-2010

OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a...

Name: Z-0968-2010 OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a...
Creator: Quest Products Inc.
Published: 2008-11-07
License: https://open.fda.gov/license/

Quest Products, Inc / initiated 2008-11-07 / Terminated

FDA source

Quest Products Inc. began a recall of 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... on 2008-11-07. The reason FDA records is "The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0968-2010
Status: Terminated
Initiated: 2008-11-07
Posted: 2010-03-03
Terminated: 2010-03-03
Recalling firm: Quest Products, Inc
Product: 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.
Product code: NGE Test, Luteinizing Hormone (Lh), Over The Counter
Reason for recall: The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.
FDA root cause: Other
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.
Quantity in commerce: 3,930 cases
Distribution: Nationwide
Product codes and lots: UPC 8 50877 00055 5, all lots

Product code NGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)