Z-2387-2010

Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and...

Name: Z-2387-2010 Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2010-02-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-26 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system on 2010-02-26. The reason FDA records is "There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed". 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-2387-2010
Status: Terminated
Initiated: 2010-02-26
Posted: 2010-09-09
Terminated: 2010-10-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued an Urgent field Safety Notice, dated February 2010, to all affected customers informing them of the problem. Customers have been told to run calibrators from cups when calibrating or request a replacement lot. The notification should be forwarded to that this product was further distributed to. Siemens Technical Solutions Center should be contacted at 800-441-9250, if they are any technical questions.
Quantity in commerce: 1310 cartons
Distribution: Worldwide Distribution -- USA, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand.
Product codes and lots: Lot number 9GM001 exp 7/2010

Product code JIX

K061703Class IIDimension Vista Chemistry 2 Calibrator (Chem 2 Cal, Kc120)Dade Behring, Inc. / cleared 2006-08-02

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)