Events

Recall of LEICA BOND UNIVERSAL COVERTILES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA BIOSYSTEMS RICHMOND 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
    14687
  • Event Risk Class
    III
  • Event Initiated Date
    2014-11-07
  • 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
    The outside barcode label may contain a lot number that does not match the lot number on the product label. the inner packaging has not been affected and contains the correct identifying lot number. the incorrect outer packaging label does not affect the form fit or function of the product.

Device

LEICA BOND UNIVERSAL COVERTILES
  • Model / Serial
    Model Catalog: S21.2001 (Lot serial: 4530962379); Model Catalog: S21.2001 (Lot serial: 4530969514)
  • Product Description
    Bond Universal Covertiles
  • Manufacturer
    LEICA BIOSYSTEMS RICHMOND INC.

Manufacturer

LEICA BIOSYSTEMS RICHMOND INC.