Z-2553-2014Class II

Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety...

Name: Z-2553-2014 Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-07-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-07-16 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of... on 2014-07-16. FDA classified it as Class II and gives the reason as "The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2553-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-16
Posted: 2014-08-26
Terminated: 2014-12-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down.
Quantity in commerce: 2757
Distribution: Nationwide and internationally, including Canada and Mexico
Product codes and lots: All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2553-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2553-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26

Product code JJE

K130276Class IDimension Exl with Lm SystemSiemens Healthcare Diagnostics, Inc. / cleared 2013-03-22

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)