Recall Z-0968-2010 ยท NGE Test, Luteinizing Hormone (Lh), Over The Counter
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 pred
| Date | Mar 3, 2010 (initiated Nov 7, 2008) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.