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U.S. Department of Health and Human Services

Class 3 Device Recall Thyrotest TSH POC Rapid membrane test

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 Class 3 Recall
Thyrotest TSH POC Rapid membrane test
see related information
Date Posted March 22, 2007
Recall Status1 Terminated on June 04, 2007
Recall Number Z-0646-2007
Recall Event ID 37473
Premarket Notification
510(K) Number
K030912 
Product Classification Radioimmunoassay, Thyroid-Stimulating Hormone - Product Code JLW
Product Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
Code Information Product Code 1020, Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
Recalling Firm/
Manufacturer
ThyroTec Inc
1801 Horseshoe Pike Ste 1
Honey Brook, Pennsylvania 19344-8500
For Additional Information Contact Jim Small
610-942-8971
Manufacturer Reason
for Recall
Positive control showed little or no positive line.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 1/24/07 the recalling firm notified their only customer of the problem. On 2/5/07, the distributor issued recall letters to their customers informing of the problem and the need to destroy the kits. The kits from lot number 02106-06 were returned to the recalling firm.
Quantity in Commerce 484 units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JLW and Original Applicant = THRYOTEC
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