Z-2133-2014Class III

Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids

Name: Z-2133-2014 Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-05-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-05-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids on 2014-05-27. FDA classified it as Class III and gives the reason as "There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of...". 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-2133-2014
Classification: Class III
Status: Terminated
Initiated: 2014-05-27
Posted: 2014-07-30
Terminated: 2014-12-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.
Quantity in commerce: 15
Distribution: FL LA AR IA OH OH WI IL LA KS MT
Product codes and lots: DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2133-2014	Class III	Terminated	Voluntary: Firm initiated	2014-08-06	2014-07-30

Product code JJE

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)