Events

Recall of BOND MAX SYSTEM - USHER2(ORACLE HER2 BOND IHC SYSTEM)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS CANADA.

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
    77949
  • Event Risk Class
    III
  • Event Initiated Date
    2011-05-23
  • 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
    Leica biosystems recently became aware that there is a potential issue with the bond oracle her ihc system ta9145 lot numbers 12135 and 13341. they have become aware of a potential occurrence of over-staining on procedural control cell-lines that are supplied as part of the system. there is the possibility that the over-staining may be observed in in-house tissue controls and/or patient tissue.

Device

BOND MAX SYSTEM - USHER2(ORACLE HER2 BOND IHC SYSTEM)
  • Model / Serial
    Model Catalog: TA9145 (Lot serial: 13341); Model Catalog: TA9145 (Lot serial: 12135)
  • Product Description
    BOND MAX SYSTEM-USHER2(ORACLE HER2 BOND IHC SYSTEM)
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA