Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
FDA device recall Z-0919-2007 · posted 2007-06-09 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LEH
- Quantity affected
- 662
- Distribution
- Nationwide.
- Date initiated
- 2007-04-30
- Date posted
- 2007-06-09
- Date terminated
- 2007-12-17
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENZYME IMMUNOASSAY, VANCOMYCIN (K060586) | Roche Diagnostics Corp. | 2006-05-11 |