AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
This recall has been terminated (originally issued July 20, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- March 10, 2004
- Posted
- July 20, 2004
- Terminated
- January 7, 2005
- Recall Number
- Z-0933-04
- Quantity
- 3
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Marketed without PMA or 510(k) approval.
Distribution
Florida and Virginia.
Lot / Code Info
Lot E11927; exp. 10/04.
Root Cause
Other
Action Taken
Consignees were notified of the removal by phone on 3/10/04.
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