Nov

2013

1650,1800,2400 Software Systems Cl II ADVIA 1200

Company: Siemens Healthcare Diagnostics
Date of Enforcement Report: 11/27/2013
Class lI:

PRODUCT

ADVIA 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.Recall Number Z-0343-2014, Z-0344-2014, Z-0345-2014, Z-0346-2014

REASON
iemens 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.

RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Tarrytown, NY on 9/3/2013. Voluntary: Firm Initiated recall is ongoing.

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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1650,1800,2400 Software Systems Cl II ADVIA 1200

Amy Sellers

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