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Terminated

Device to determine quantitative total testosterone in human serum

FDA Recall Z-0090-04 · Posted 2003-11-06

Recalling FirmQualigen Inc
Recall StatusTerminated
Product CodeCDZ
Date Initiated2003-09-19
Date Terminated2004-03-30
Product Quantity81 Kits

Reason for Recall

Kits may produce results that are falsely elevated.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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