Z-0090-04

Device to determine quantitative total testosterone in human serum

Name: Z-0090-04 Device to determine quantitative total testosterone in human serum
Creator: Qualigen Inc
Published: 2003-09-19
License: https://open.fda.gov/license/

Qualigen Inc / initiated 2003-09-19 / Terminated

FDA source

Qualigen Inc began a recall of Device to determine quantitative total testosterone in human serum on 2003-09-19. The reason FDA records is "Kits may produce results that are falsely elevated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0090-04
Status: Terminated
Initiated: 2003-09-19
Posted: 2003-11-06
Terminated: 2004-03-30
Recalling firm: Qualigen Inc
Product: Device to determine quantitative total testosterone in human serum
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: Kits may produce results that are falsely elevated.
FDA root 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.
Product codes and lots: Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009

Product code CDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)