Events

Recall of BOND POLYMER REFINE RED DETECTION

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS 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
    56051
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-27
  • 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 some detection kits may have been subject to a manufacturing error which could result in inadequate staining. if the product is used according to the instructions for use with the adequate controls the end user would be able to identify the test has not stained correctly.

Device

BOND POLYMER REFINE RED DETECTION
  • Model / Serial
    Model Catalog: DS9390 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    BOND POLYMER REFINE RED DETECTION DS9390
  • Manufacturer
    LEICA MICROSYSTEMS INC.

Manufacturer

LEICA MICROSYSTEMS INC.