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Terminated

Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.

FDA Recall Z-0919-2007 · Posted 2007-06-09

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLEH
Date Initiated2007-04-30
Date Terminated2007-12-17
Product Quantity662

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060586ENZYME IMMUNOASSAY, VANCOMYCINRoche Diagnostics Corp. · 2006-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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