AMPLICOR HPV Master Mix Analyte Specific Reagent (HPV MMX), Catalog number 03582841190.
FDA device recall Z-0933-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Marketed without PMA or 510(k) approval.
- Action taken
- Consignees were notified of the removal by phone on 3/10/04.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 3
- Distribution
- Florida and Virginia.
- Date initiated
- 2004-03-10
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-07
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.