Recall Z-1047-2013— Siemens Healthcare Diagnostics, Inc.
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-02-27, terminated 2014-01-14. It names one FDA 510(k) clearance: K073604. 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.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-02-27
- Terminated
- 2014-01-14
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.