Device to determine quantitative total testosterone in human serum
This recall has been terminated (originally issued November 6, 2003).
- Company
- Qualigen Inc
- Recall Initiated
- September 19, 2003
- Posted
- November 6, 2003
- Terminated
- March 30, 2004
- Recall Number
- Z-0090-04
- Quantity
- 81 Kits
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Kits may produce results that are falsely elevated.
Distribution
Nationwide and Switzerland.
Lot / Code Info
Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009
Root Cause
Other
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.
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