Recall Z-0755-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Feb 4, 2016 (initiated Oct 7, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | On October 7, 2015 Siemens Healthcare Diagnostics distributed Urgent Field Safety Notices to their custoemrs via Fed Ex in the U.S. and via email to regional countries for implementation outside of the U.S. Customers were provided a work-around if they have experienced any of the following problems: 1) Intermittent auto-startup function fails, 2) calibration interval resets as though a full calibration was performed, 3) Users may be unaware that the QC definition screen with +/- suggests a 2 Standard Deviation range value, 4) a rescanned and re-queried sample may become stuck in a communicati |
| Quantity | 87 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |