Mar

2008

Ventana Image Analysis System (VIAS) Cl II

Company: Ventana Image Analysis System (VIAS),
Date of Enforcement Report 3/26/2008
Class:ll

PRODUCT
Ventana Image Analysis System (VIAS) – PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Recall # Z-0571-2008

REASON
Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Ventana Medical Systems Inc., Tucson, AZ, by telephone beginning in June 20007 and by letter dated August 17, 2007.
Manufacturer: Bd Diagnostic Systems Tripath, Durham, NC. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
77 devices

DISTRIBUTION
Nationwide and Canada

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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Ventana Image Analysis System (VIAS) Cl II

Amy Sellers

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