Events

Recall of PATHWAY HER2 (4B5)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventana Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53597
  • Event Risk Class
    Class 2
  • Event Number
    Z-1146-2010
  • Event Initiated Date
    2009-09-17
  • Event Date Posted
    2010-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85961
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    in vitro diagnostic - Product Code MVC
  • Reason
    Incorrect result: light staining inconsistencies with lot number 680957 of the ventana pathway her-2/neu (4b5) rabbit monoclonal primary antibody.
  • 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.

Device

PATHWAY HER2 (4B5)
  • Model / Serial
    Lot number: 680957
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Austria, Denmark, Germany, Hungary, Netherlands, Sweden, United Kingdom, Brazil, Canada, India, Korea, Morocco & Thailand
  • Product Description
    VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY || (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Manufacturer Address
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    USFDA