AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
FDA Recall Z-0934-04 · 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.