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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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)
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots 144114, exp. 9/30/2007, 144167, exp. 12/31/2007, 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.
Products Sold
Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.
Roche Diagnostics Corp. is recalling Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P; Catalog due to Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026