Z-0864-2010

Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is...

Name: Z-0864-2010 Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-08-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-08-31 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration... on 2009-08-31. The reason FDA records is "Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0864-2010
Status: Terminated
Initiated: 2009-08-31
Posted: 2010-02-26
Terminated: 2010-12-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods on the Dimension Vista System
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001.
Root cause tag: manufacturing process
FDA root cause: Other
Action: An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.
Quantity in commerce: 1474 Cartons
Distribution: Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
Product codes and lots: Lot Number 9DM001

Product code JIX

K061838Class IIDimension Vista Chemistry 1 Calibrator, Model Kc110Dade Behring, Inc. / cleared 2006-08-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)