Class 2 Device Recall ADVIA Chemistry XPT

• Date Initiated by Firm: August 28, 2015
• Create Date: October 30, 2015
• Recall Status: Terminated on May 22, 2018
• Recall Number: Z-0183-2016
• Recall Event ID: 72104
• 510(K)Number: K990346
• Product Classification: Electrode, ion specific, sodium - Product Code JGS
• 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.
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc.; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Ranjan Sadarangani; 914-524-2868
• Manufacturer 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: 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JGS