Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
This recall has been terminated (originally issued June 9, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- April 30, 2007
- Posted
- June 9, 2007
- Terminated
- December 17, 2007
- Recall Number
- Z-0919-2007
- Quantity
- 662
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
Distribution
Nationwide.
Lot / Code Info
Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007.
Root Cause
Other
Action Taken
Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.
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