FDA Recall
Terminated
AMPLICOR HPV Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
Recall: Z-0934-04
·
Initiated March 10, 2004
Recall
- Recall Number
- Z-0934-04
- 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 Microwell Plate Analyte Specific Reagent (MWP); catalog 03579229190.
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