Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/10/2013
Class lll:
PRODUCT
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. Recall Number Z-1046-2013
REASON
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 has validated a new limit for System Check LOCI results that can be used with Software Version 10.0 in order to resolve the issue
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Newark, DE, on 3/27/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2207 total
DISTRIBUTION
Nationwide and Internationally
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