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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA 1200 System Software: 1) V2.00, 2) V2.01

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 Class 2 Device Recall ADVIA 1200 System Software: 1) V2.00, 2) V2.01see related information
Date Initiated by FirmSeptember 03, 2013
Date PostedNovember 18, 2013
Recall Status1 Terminated 3 on March 07, 2017
Recall NumberZ-0343-2014
Recall Event ID 66069
510(K)NumberK990346 
Product Classification Electrode, ion specific, sodium - Product Code JGS
ProductADVIA 1200 System Software: 1) V2.00, 2) V2.01. 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) 10386841, 2) 10469445
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-524-2955
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
ActionOn 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 Commerce625 units
DistributionWorldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JGS
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