Recall Z-0920-2007 ยท LEG Enzyme Immunoassay, Valproic Acid
Roche Diagnostics Corp.
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
| 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 | 992 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060690 | ONLINE VALPROIC ACID Roche Diagnostics Corp., Aug 8, 2006 |