Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyze…

Recall date

August 28, 2015

Source

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

Recall number

Z-0183-2016

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

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.

Why it was recalled

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.

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 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.