Z-1076-2014Class II

Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte...

Name: Z-1076-2014 Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-01-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-01-06 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY)... on 2014-01-06. FDA classified it as Class II and gives the reason as "Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL)". 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-1076-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Posted: 2014-02-24
Terminated: 2015-05-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A recall notification letter, dated January 2014, was sent to Users.
Quantity in commerce: 3496
Distribution: Nationwide Distribution.
Product codes and lots: lot 3FD034, exp. 6/17/2014, and lot 3HD012, exp. 9/1/2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1076-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1076-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-05	2014-02-24

Product code JIX

K061923Class IIDimension Vista Enzyme 1 Calibrator (Enz 1 Cal - Kc310)Dade Behring, Inc. / cleared 2006-08-25

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)