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Terminated

AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.

FDA Recall Z-0933-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Date Initiated2004-03-10
Date Terminated2005-01-07
Product Quantity3

Reason for Recall

Marketed without PMA or 510(k) approval.

Firm Action

Consignees were notified of the removal by phone on 3/10/04.

Root Cause

Other

Distribution Pattern

Florida and Virginia.

Official Source

View FDA Recall →

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

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