Z-1535-2010

Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON)...

Name: Z-1535-2010 Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON)...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-10-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-10-23 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the... on 2009-10-23. The reason FDA records is "patient results are depressed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1535-2010
Status: Terminated
Initiated: 2009-10-23
Posted: 2010-05-04
Terminated: 2010-06-22
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Cardon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: patient results are depressed
FDA root cause: Other
Action: An "Urgent Field Safety Notice" dated October 2009 was issued by Siemens to all customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to recalibrate the AMON method (AMON Flex reagent cartridge, K3019) with Vista Chem 3 Claibrator lot 9ED058 using the revised bottle values provided in the notice and to please consult with their laboratory director regarding re-evaluation of previous results. The customers should forward this notification to anyone to whom they may have distributed this product. If you have any technical questions regarding this information, please contact Siemens Technical Solutions Center at 1-800-441-9250.
Quantity in commerce: 1753 cartons
Distribution: Worldwide distribution: USA and Australia, Canada, Japan, New Zealand, South Korea, and Switzerland.
Product codes and lots: Catalog number KC130. Lot number 9ED058 exp 5/1/10

Product code JIX

K062334Class IIDimension Vista Chemistry 3 Calibrator, Model Kc130Dade Behring, Inc. / cleared 2006-09-22

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)