Class 2 Device Recall FastPack Total Testosterone Immunoassay

• Date Initiated by Firm: September 19, 2003
• Date Posted: November 06, 2003
• Recall Status: Terminated 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: 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.