Device to determine quantitative total testosterone in human serum
FDA device recall Z-0090-04 · posted 2003-11-06 · Terminated
Recall details
- Recalling firm
- Qualigen Inc
- Reason for recall
- Kits may produce results that are falsely elevated.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CDZ
- Quantity affected
- 81 Kits
- Distribution
- Nationwide and Switzerland.
- Date initiated
- 2003-09-19
- Date posted
- 2003-11-06
- Date terminated
- 2004-03-30
- Location
- Carlsbad, CA
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