Skip to content
Recall Observatory FDA recall evidence

Device product

Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety of analytes in human body fluids.

Z-1048-2013

February 27, 2013

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 64570
Status
Terminated
Classification
Class III
Quantity
2207 total
Official record key
device-enforcement:Z-1048-2013

Official wording

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

Code information: Siemens Material Number 10636929

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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