Z-0652-2017Class II

Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product...

Name: Z-0652-2017 Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-09-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-09-15 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol... on 2016-09-15. FDA classified it as Class II and gives the reason as "Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0652-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Posted: 2016-11-22
Terminated: 2018-05-31
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA/CRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista System
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082.
FDA root cause: Under Investigation by firm
Action: Siemens mailed an Urgent Medical Device recall notification letter on September 19, 2016 to notify affected customers who purchased the product and to make them aware of the potential risk to health and the actions to be taken. For questions regarding tis recall. For questions regarding this recall call 1-800-441-9250.
Quantity in commerce: 9,935 units
Distribution: Worldwide Distribution - US (Nationwide) Internationally to Australia, Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Netherlands, New Zealand, Norway, Portugal, Qatar, Saudi Arabia, South Korea, Slovakia, Slovenia, Spain, and Switzerland.
Product codes and lots: Device Listing Number: D011448 (Kc110) and D244577 (KC110B) Lot numbers: MGM081 and MGM082

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0652-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0652-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-30	2016-11-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)