Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
Reported: April 10, 2013 Initiated: February 27, 2013 #Z-1046-2013
Product Description
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
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
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 2207 total
- Distribution
- Worldwide Distribution.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 2207 total.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2013. Severity: Low. Recall number: Z-1046-2013.
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