Recall Z-0183-2016 ยท JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Aug 28, 2015 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Urgent Medical Device Correction letters (dated 8/27/2015) and Field Correction Effectiveness Check Forms were sent to customers via FedEx starting on 8/28/2015, informing them of the potential for discrepant ISE results. Customers must follow the instructions provided in the letter. The Actions to Be Taken section of the letter notes that customers must ensure that the electrodes are fully plugged in after replacement, washing or maintenance activities, followed by performing an ISE Calibration and running 2 levels of Quality Control material. Urgent Field Safety Notices were sent to custo |
| Quantity | Domestic: 15 units; Foreign: 59 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990346 | BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp., May 21, 1999 |