FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
- Recall number
- Z-0919-2007
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
- Status
- Terminated
- Initiated
- 2007-04-30
- Posted
- 2007-06-09
- Terminated
- 2007-12-17
- 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.
- Lot, serial or model codes
- Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007.
- 510(k) numbers
- ["K060586"]
- PMA numbers
- not on file
- Product code
- LEH
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28