Z-1046-2013Class III

Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes...

Name: Z-1046-2013 Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-02-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-02-27 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids on 2013-02-27. FDA classified it as Class III and gives the reason as "Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1046-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-27
Posted: 2013-04-01
Terminated: 2014-01-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h
FDA root cause: Under Investigation by firm
Action: Siemens initiated their recall of this product on February 27, 2013 by sending an Important Customer Notification letter to consignees by FedEx. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 2207 total
Distribution: Worldwide Distribution.
Product codes and lots: Siemens Material Number 10486890

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1046-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1046-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1047-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01
Z-1048-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-01

Product code JJE

K073604Class IIDimension Exl with Lm Clinical Chemistry System, Dimension Ft4l Flex Reagent Cartridge, and Loci Thyroid Calibrator, ModDade Behring, Inc. / cleared 2008-03-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)