Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and pu
FDA device recall Z-1372-06 · posted 2006-08-05 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue, resulting in the user believing the instrument has been decontaminated when it has not .
- Action taken
- Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle.
- Root cause
- Other
- Status
- Terminated
- Product code
- NPQ
- Quantity affected
- 771 total for recalls Z-1372-1374-06
- Distribution
- Nationwide.
- Date initiated
- 2006-07-17
- Date posted
- 2006-08-05
- Date terminated
- 2007-12-04
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.