Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
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-0920-2007
- Quantity
- 992
- 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 144107, exp. 9/30/2007; 144166, exp. 1/31/2008, and 144208, exp. 6/30/2008
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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