Roche Diagnostics Corp. Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lots 144174, exp. 7/31/2007, 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007.
Products Sold
Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007.
Roche Diagnostics Corp. is recalling Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.0 due to Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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