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U.S. Department of Health and Human Services

Class 2 Device Recall OvuChek

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 Class 2 Device Recall OvuCheksee related information
Date Initiated by FirmNovember 07, 2008
Date PostedMarch 03, 2010
Recall Status1 Terminated 3 on March 03, 2010
Recall NumberZ-0968-2010
Recall Event ID 52901
Product Classification Test, luteinizing hormone (1h), over the counter - Product Code NGE
ProductOvuChek 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.
Code Information UPC 8 50877 00055 5, all lots
FEI Number 3005857009
Recalling Firm/
Manufacturer		 Quest Products Inc.
14052 W Petronella Dr Ste 103
Libertyville IL 60048-9512
For Additional Information ContactMr. Donald G. Ryan
847-816-1823
Manufacturer Reason
for Recall		The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.
FDA Determined
Cause 2		Other
ActionQuest 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 Commerce3,930 cases
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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