Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note:
FDA device recall Z-0918-2007 · posted 2007-06-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.
- Action taken
- Foreign affiliates were notified via email letter dated 4/5/07 requesting that to notify their customers of the need to implement a special wash cycle to prevent reagent carry over.
- Root cause
- Other
- Status
- Terminated
- Product code
- KLB
- Quantity affected
- 474 total (Z-0917-0918-2007)
- Distribution
- International Distribution ONLY-Australia, Canada and Germany.
- Date initiated
- 2007-04-05
- Date posted
- 2007-06-09
- Date terminated
- 2008-04-30
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONLINE TDM TOBRAMYCIN (K060853) | Roche Diagnostics Corp. | 2006-06-09 |