—#51550

Product

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

FDA product code: LEH — Radioimmunoassay, Vancomycin
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K060586
Affected lot / code info: Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-04-30
Posted by FDA: 2007-06-09
Terminated: 2007-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51550. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.