Date Initiated by Firm |
November 07, 2008 |
Date Posted |
March 03, 2010 |
Recall Status1 |
Terminated 3 on March 03, 2010 |
Recall Number |
Z-0968-2010 |
Recall Event ID |
52901 |
Product Classification |
Test, luteinizing hormone (1h), over the counter - Product Code NGE
|
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. |
Code Information |
UPC 8 50877 00055 5, all lots |
Recalling Firm/ Manufacturer |
Quest Products Inc. 14052 W Petronella Dr Ste 103 Libertyville IL 60048-9512
|
For Additional Information Contact |
Mr. 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 |
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 |
Total Product Life Cycle |
TPLC Device Report
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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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