FDA Medical Device Recalls (openFDA)
Qualigen Inc: Device to determine quantitative total testosterone in human serum
- Recall number
- Z-0090-04
- Recalling firm
- Qualigen Inc
- Product
- Device to determine quantitative total testosterone in human serum
- Status
- Terminated
- Initiated
- 2003-09-19
- Posted
- 2003-11-06
- Terminated
- 2004-03-30
- Reason
- Kits may produce results that are falsely elevated.
- 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
- 81 Kits
- Distribution
- Nationwide and Switzerland.
- Lot, serial or model codes
- Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CDZ
- Firm FEI
- 3003355251
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28