Company: Siemens Healthcare Diagnostics, Inc..
Date of Enforcement Report 2/10/2016
Class lI:
PRODUCT
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. Recall Number Z-0755-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY on 10/7/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
87 units
DISTRIBUTION
Nationwide and Internationally
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