Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0755-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.

Product Classification:

Class II

Date Initiated: October 7, 2015

Date Posted: February 10, 2016

Recall Number: Z-0755-2016

Event ID: 72391

Reason for Recall:

Multiple Software issues. Auto Start-UP Fail, Calibration Interval Resets when a Reagent Blank is run, Control Definition screen assumes range defined is 2 SD, Laboratory Information System (LIS) communication/Laboratory Automation (LAS) issue, Printer Driver Resets, ISE Calibration Ranges are too conservative for Urine Sodium, Archiving and deletion may fail and Workstation services may restart.

Status: Terminated

Product Quantity: 87 units

Code Information:

Software Version 1.0.3

Distribution Pattern:

Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated