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/ 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 2 |
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 and Original Applicant = THRYOTEC
|