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