Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum,…

Recall date

October 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0755-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.