Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1048-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: February 27, 2013

Date Posted: April 10, 2013

Recall Number: Z-1048-2013

Event ID: 64570

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

Status: Terminated

Product Quantity: 2207 total

Code Information:

Siemens Material Number 10636929

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated