Qualigen Inc Device to determine quantitative total testosterone in human serum Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Device to determine quantitative total testosterone in human serum
Brand
Qualigen Inc
Lot Codes / Batch Numbers
Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009
Products Sold
Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009
Qualigen Inc is recalling Device to determine quantitative total testosterone in human serum due to Kits may produce results that are falsely elevated.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Kits may produce results that are falsely elevated.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026