Chiron IVD Analyzer Class II


Software may incorrectly link previous assay results to a
different patient ID.


Chiron Diagnostics Automated Chemiluminescence System, Model

ADVIA:CENTAUR for the quantitative determination of various in
vitro diagnostic assays using direct chemiluminescent technology.

Recall #Z-358/359-0.


Catalog Numbers: 114564, 572561, 572562, 572563, 572564,
and 572566. All ADVIA:Centaur Immunoassay Analyzers with
versions 2.01 and 2.11.


Bayer Corporation, Oberlin, Ohio.


Manufacturer, by customer bulletin on December 22, 1999.

Firm-initiated field correction ongoing.


Nationwide and international.


660 units.

About the author

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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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