Recall Z-0090-04 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Qualigen Inc
Device to determine quantitative total testosterone in human serum
| Date | Nov 6, 2003 (initiated Sep 19, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.