Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0183-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.

Product Classification:

Class II

Date Initiated: August 28, 2015

Date Posted: November 4, 2015

Recall Number: Z-0183-2016

Event ID: 72104

Reason for Recall:

ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples.

Status: Terminated

Product Quantity: Domestic: 15 units; Foreign: 59 units

Code Information:

All serial numbers

Distribution Pattern:

Worldwide Distribution -- US, Australia, Bahrain, Denmark, Egypt, Egypt, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Republic Korea, Singapore, Slovakia, Spain, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated