Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)
This recall has been terminated (originally issued June 9, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- April 5, 2007
- Posted
- June 9, 2007
- Terminated
- April 30, 2008
- Recall Number
- Z-0918-2007
- Quantity
- 474 total (Z-0917-0918-2007)
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
International Distribution ONLY-Australia, Canada and Germany.
Lot / Code Info
Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.
Root Cause
Other
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.