Z-2720-2014Class II

Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the...

Name: Z-2720-2014 Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-08-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-08-18 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL)... on 2014-08-18. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081...". 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-2720-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-18
Posted: 2014-09-30
Terminated: 2015-02-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The 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), 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 Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens confirms that QC and patient samples under-recovers MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Siemens sent an Urgent Medical Device Dorrection letter, dated August 2014, to all affected consignees. The letter identified the product, the problem, and the actions to be taken. Consignees were instructed if they still have an active calibration of MG with this lot of CHEM 1 CAL, they should immediately calibrate MG with an alternate lot of CHEM 1 CAL. Consigness were instructed to retain the letter with their laboratory records, and to forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center - Techhnical Solutions or their local Siemens technical support representative.
Quantity in commerce: 9769 Total (6000 US)
Distribution: Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland
Product codes and lots: lot 3GM081, exp. 07-01-2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2720-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2720-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29

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)