Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Mode

FDA device recall Z-0571-2008 · posted 2008-03-18 · Terminated

Recall details

Recalling firm

Ventana Medical Systems Inc

Reason for recall

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.

Action taken

Beginning in 6/07, Ventana Medical Systems, Inc., made phonecalls to labs asking to confirm software version, date of upgrade if available and confirmation of whether site uses 4B5 and Imaging together. A phone script was provided. Customers with systems not ugraded were to upgrade before further use of system. A notification letter dated 8/17/2007 was later sent to VIAS customers advising that the software upgrade from February 1 , 2007 may not have been completed on their system. This software upgrade adds the algorithm (Slidetype) for the PATWAY anti-HER-2/neu (4B5) antibody to their VIAS system . This Slidetype is cleared for marketing and is required prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5). The letter also advises that their VIAS and NEXES systems are conneded to the internet which enables this upgrade to be performed remotely with the support of the Ventana Medical Systems Customer Support Center (CSC). customers are instructed to call the CSC to carry out the upgrade or to schedule a Technical Applications Specialist (TAS) to assist with the upgrade in their lab. Arrangements for the upgrade are to be made prior to imaging slides stained with PATHWAY anti-HER-2/neu (4B5).

Root cause

Software change control

Status

Terminated

Product code

NQN

Quantity affected

77 devices

Distribution

Nationwide and Canada

Date initiated

2007-06-26

Date posted

2008-03-18

Date terminated

2012-03-26

Location

Tucson, AZ

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