FDA Recall
Terminated
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
Recall: Z-0933-04
·
Initiated March 10, 2004
Recall
- Recall Number
- Z-0933-04
- Event Number
- 28739
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 10, 2004
- Posted
- July 20, 2004
- Terminated
- January 7, 2005
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
Reason
Marketed without PMA or 510(k) approval.
Action
Consignees were notified of the removal by phone on 3/10/04.
Distribution
Florida and Virginia.
Quantity
3