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U.S. Department of Health and Human Services

Class 2 Device Recall PATHWAY HER2 (4B5)

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 Class 2 Recall
PATHWAY HER2 (4B5)
see related information
Date Posted March 16, 2010
Recall Status1 Terminated on April 22, 2010
Recall Number Z-1146-2010
Recall Event ID 53597
Premarket Approval
PMA Number
P990081
Product Classification System, Test, Her-2/Neu, Ihc - Product Code MVC
Product VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
Code Information Lot number: 680957
Recalling Firm/
Manufacturer
Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson, Arizona 85755
Manufacturer Reason
for Recall
Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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.
Quantity in Commerce 433 units
Distribution Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MVC and Applicant = VENTANA MEDICAL SYSTEMS, INC.
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