Events

Recall of JONES STAINING KIT

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
    151846
  • Event Risk Class
    III
  • Event Initiated Date
    2010-10-13
  • 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
    An incorrect expiration date was assigned to the kit registration button on lot #812498. the correct expiration date of 15-oct-2010 appears on the label while the incorrect date of 30-sep-2011 will register in the nexes software.

Device

JONES STAINING KIT
  • Model / Serial
    Model Catalog: P/N 860-019 (Lot serial: 812498)
  • Product Description
    Jones Staining Kit
  • Manufacturer
    VENTANA MEDICAL SYSTEMS INC

Manufacturer

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