Events

Recall of PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

According to Health Canada (via FOI), this recall involved a device in Canada 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
    107234
  • Event Risk Class
    III
  • Event Initiated Date
    2009-09-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Pathway anti-her-2/neu (4b5) rabbit monoclonal primary antibody lot#680957 is staining light when compared to other namufactured pathway her2 (4b5) lots. this issue is isolated to this lot.

Device

PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
  • Model / Serial
    Model Catalog: 790-2991 (Lot serial: Lot#680957)
  • Product Description
    MONOCLONAL PRIMARY ANTIBODY
  • Manufacturer
    VENTANA MEDICAL SYSTEMS INC

Manufacturer

VENTANA MEDICAL SYSTEMS INC
  • Manufacturer Address
    TUCSON
  • Manufacturer Parent Company (2017)
    Roche Holding Ag
  • Source
    HC