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U.S. Department of Health and Human Services

Class 2 Device Recall FastPack Total Testosterone Immunoassay

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  Class 2 Device Recall FastPack Total Testosterone Immunoassay see related information
Date Initiated by Firm September 19, 2003
Date Posted November 06, 2003
Recall Status1 Terminated 3 on March 30, 2004
Recall Number Z-0090-04
Recall Event ID 27562
Product Classification Radioimmunoassay, Testosterones And Dihydrotestosterone - Product Code CDZ
Product Device to determine quantitative total testosterone in human serum
Code Information Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009 
Recalling Firm/
Manufacturer		 Qualigen Inc
2042 Corte Del Nogal
Carlsbad CA 92009-1438
For Additional Information Contact Dorothy Deinzer
760-918-9165
Manufacturer Reason
for Recall		 Kits may produce results that are falsely elevated.
FDA Determined
Cause 2		 Other
Action All customers who received any one of the three lots have been faxed a removal letter starting 09/24/03. Certified or Airborne letter sent on 09/29/03.
Quantity in Commerce 81 Kits
Distribution Nationwide and Switzerland.
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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