FDA Device

Device to determine quantitative total testosterone in human serum

Hazard

Kits may produce results that are falsely elevated.

What You Should Do

Remedy

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.

Products

Device to determine quantitative total testosterone in human serum
Brand
Qualigen Inc
UPC
Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009

Units Affected

81 Kits