Events

Recall of LEICA PELORIS

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
    42115
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-10
  • 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 peloris ii tissue processor potentially has a faulty impellor. this potenial non-conformance has the capability to lead to reagent carry-over from one processing step to another. the non-conforming impellors have a faulty seal which could result in reagent seeping into and out of the impellor cavity during tissue processing. the total volume of reagent that could seep uncontrollably in and out of the impellor cavity is less than 1ml.

Device

LEICA PELORIS
  • Model / Serial
    Model Catalog: 26.0005 (Lot serial: S/N: 0265062B)
  • Product Description
    LEICA PELORIS RAPID TISSUE PROCESSOR
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA