• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA 1650 System Software: 1) V4.01, 2) V3.52

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall ADVIA 1650 System Software: 1) V4.01, 2) V3.52 see related information
Date Initiated by Firm September 03, 2013
Date Posted November 18, 2013
Recall Status1 Terminated 3 on March 07, 2017
Recall Number Z-0344-2014
Recall Event ID 66069
510(K)Number K990346  
Product Classification Electrode, ion specific, sodium - Product Code JGS
Product ADVIA 1650 System Software: 1) V4.01, 2) V3.52.

Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Code Information Product Codes: 1) 10318424, 2) 10285281
Recalling Firm/
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
Manufacturer Reason
for Recall
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
FDA Determined
Cause 2
Software design
Action On September 3, 2013, Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice for the ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems due to a software issue. The software issue has caused the Chemistry Systems to generate reports without error flags. Notices were sent to domestic customers via U.S. and outside the US the distribution is determined at the country level. The customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue at 877-229-3711 (prompt 18).
Quantity in Commerce 892 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
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 and Original Applicant = BAYER CORP.