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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 Device Recall Thyrotest TSH POC Rapid membrane test see related information
Date Initiated by Firm January 24, 2007
Date Posted March 22, 2007
Recall Status1 Terminated 3 on June 04, 2007
Recall Number Z-0646-2007
Recall Event ID 37473
510(K)Number K030912  
Product Classification In vitro diagnostic - 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/
ThyroTec Inc
1801 Horseshoe Pike Ste 1
Honey Brook PA 19344-8500
For Additional Information Contact Jim Small
Manufacturer Reason
for Recall
Positive control showed little or no positive line.
FDA Determined
Cause 2
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 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.
510(K) Database 510(K)s with Product Code = JLW and Original Applicant = THRYOTEC