Recall Z-0917-2007 ยท KLB Radioimmunoassay, Tobramycin
Roche Diagnostics Corp.
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog No. 04642511190. (Note: Not distributed within the United States)
| Date | Jun 9, 2007 (initiated Apr 5, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 474 total (Z-0917-0918-2007) |
| Distribution | International Distribution ONLY-Australia, Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060853 | ONLINE TDM TOBRAMYCIN Roche Diagnostics Corp., Jun 9, 2006 |