Class 3 Device Recall Thyrotest TSH POC Rapid membrane test

• Date Initiated by Firm: January 24, 2007
• Date Posted: March 22, 2007
• Recall Status: Terminated 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/ Manufacturer: ThyroTec Inc; 1801 Horseshoe Pike Ste 1; Honey Brook PA 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: Other
• 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