Recall Z-0919-2007 ยท LEH Radioimmunoassay, Vancomycin
Roche Diagnostics Corp.
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
| Date | Jun 9, 2007 (initiated Apr 30, 2007) |
| Status | Terminated |
| Reason | 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 | Other |
| 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. |
| Quantity | 662 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060586 | ENZYME IMMUNOASSAY, VANCOMYCIN Roche Diagnostics Corp., May 11, 2006 |