Siemens Dimension — Class III medical device recall Z-1046-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-04-10. Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in Syst
| Recall number | Z-1046-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-02-27 |
| Classified | 2013-04-01 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2014-01-14 |
| Quantity | 2,207 total |
Product
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.