FDA Device recall Z-1047-2013
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377)
- FDA Device
- Class III
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class III recall of Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377) by Siemens Healthcare Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1047-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-27 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | n/a |
Product
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a variety of analytes in human body fluids.
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 h
Identifiers
| code_info | Siemens Material Number 106393377 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2013%22
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