Recall Z-0183-2016

Reason for recall

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-determined cause: Device Design

Action taken

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 customers outside the USA. The Field Correction Effectiveness Check form should have been completed and returned. A copy of the letter should be kept with laboratory records; and, the letter should be forwarded to anyone who may have received the affected product. Customers should contact their Siemens Customer Care Center or their local Siemens technical support representative with questions.