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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry an
Recalled November 4, 2015 · FDA recall Z-0183-2016 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
Domestic: 15 units; Foreign: 59 units
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →