VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
FDA Recall Z-1146-2010 · Posted 2010-03-16
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Recalling FirmVentana Medical Systems Inc
Recall StatusTerminated
Product CodeMVC
Date Initiated2009-09-17
Date Terminated2010-04-22
Product Quantity433 units
Reason for Recall
Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.
Firm Action
The recall was initiated on 09/17/2009 with Ventana Medical Systems forwarding Urgent Voluntary Medical Device Recall letters to all the affected customers advising them to discontinue the use of lot number 680957 and have their laboratory retest with product from a different lot of PATHWAY HER2 (4B5) any breast cases scored as 0, 1+, or 2+ that were not reflexed to an approved in situ hybridization (ISH) method.
Customers were also instructed to contact Ventana Customer Support at 1-800-227-2155 and select 1 for Technical Support to speak to a Customer Support agent who will work with then to replace or credit any product from this specific lot number.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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