CLASS III Device recall · Reported 10 Apr 2013 · FDA Enforcement Report
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890) recalled
Siemens Healthcare Diagnostics is recalling Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). The recall was initiated on 27 Feb 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1046-2013
- FDA event ID
- 64570
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Feb 2013
- FDA classified
- 1 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2013 | Recall initiated by company | |
| 1 Apr 2013 | Classified by FDA | +33 days |
| 10 Apr 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Is Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890) recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890) on 27 Feb 2013. The recall is Class III and its status is Terminated. Recall number Z-1046-2013.
Why was it recalled?
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
Which lots are affected?
Siemens Material Number 10486890
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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