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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
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.
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