Z-0919-2007

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

Name: Z-0919-2007 Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190
Creator: Roche Diagnostics Corp.
Published: 2007-04-30
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-04-30 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190 on 2007-04-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0919-2007
Status: Terminated
Initiated: 2007-04-30
Posted: 2007-06-09
Terminated: 2007-12-17
Recalling firm: Roche Diagnostics GmbH
Product: Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
Product code: LEH Radioimmunoassay, Vancomycin
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.
FDA 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 in commerce: 662
Distribution: Nationwide.
Product codes and lots: Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007.

Product code LEH

K060586Class IIEnzyme Immunoassay, VancomycinRoche Diagnostics Corp. / cleared 2006-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)