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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 Device Recall PATHWAY HER2 (4B5)see related information
Date Initiated by FirmSeptember 17, 2009
Date PostedMarch 16, 2010
Recall Status1 Terminated 3 on April 22, 2010
Recall NumberZ-1146-2010
Recall Event ID 53597
PMA NumberP990081 
Product Classification in vitro diagnostic - Product Code MVC
ProductVENTANA 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 
FEI Number 1000125183
Recalling Firm/
Manufacturer		 Ventana Medical Systems Inc
1910 E Innovation Park Dr
Tucson AZ 85755
For Additional Information Contact
520-229-3928
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		Nonconforming Material/Component
ActionThe 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 Commerce433 units
DistributionWorldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = MVC
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