Date Initiated by Firm |
April 28, 2005 |
Create Date |
June 25, 2015 |
Recall Status1 |
Terminated 3 on March 16, 2012 |
Recall Number |
Z-0874-05 |
Recall Event ID |
31976 |
Product Classification |
Radioimmunoassay, Thyroid-Stimulating Hormone - Product Code JLW
|
Product |
Nichols Advantage TSH - Third Generation
|
Code Information |
Lots 62-400791 and 62-400796 |
Recalling Firm/ Manufacturer |
Nichols Institute Diagnostics 1311 Calle Batido San Clemente CA 92673-6316
|
For Additional Information Contact |
Robert L. Schmidt 949-940-7417
|
Manufacturer Reason for Recall |
Does not meet performance claims in the labeling.
|
FDA Determined Cause 2 |
Other |
Action |
Firm sent recall letter and response form April 28, 2005. Firm will follow-up to nonrespondants. |
Quantity in Commerce |
1072 |
Distribution |
Nationwide, Germany, Greece and Spain |
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.
|