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Terminated

On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label

FDA Recall Z-1202-03 · Posted 2003-09-12

Recalling FirmVarian, Inc.
Recall StatusTerminated
Product CodeDML
Date Initiated2003-07-18
Date Terminated2004-05-17
Product Quantity11847 kits (50 units/kit)

Reason for Recall

Stability in question.

Firm Action

Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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