Z-1216-2017Class III

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase...

Name: Z-1216-2017 The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-05-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-05-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST)... on 2016-05-05. FDA classified it as Class III and gives the reason as "Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material...". 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-1216-2017
Classification: Class III
Status: Terminated
Initiated: 2016-05-05
Posted: 2017-02-16
Terminated: 2018-02-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens mailed an Urgent Medical Device Notification letter to all affected customers on May 10, 2016. The notice provided information on actions to be taken by the customer to work around the issue. For further questions, please call (800) 441-9250.
Quantity in commerce: 13,147 units
Distribution: Distributed throughout the United States
Product codes and lots: Lot Number: 4MD048, 5DD026, 5ED071, 5GD004, 5JD058, 5LD061

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1216-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1216-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16
Z-1217-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-16

Product code JIX

K103612Class IIDimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. / cleared 2011-01-25

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)