FDA Medical Device Recalls (openFDA)
Quest Products Inc.: 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 number
- Z-0968-2010
- 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.
- Status
- Terminated
- Initiated
- 2008-11-07
- Posted
- 2010-03-03
- Terminated
- 2010-03-03
- Reason
- The ovulation test strips were shipped without 510(k) premarket notification clearance from the 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
- 3,930 cases
- Distribution
- Nationwide
- Lot, serial or model codes
- UPC 8 50877 00055 5, all lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NGE
- Firm FEI
- 3005857009
- Firm city
- Libertyville
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28