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
