Events

Recall of VYSIS PARAFFIN PRETREATMENT KIT

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

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
    115112
  • Event Risk Class
    III
  • Event Initiated Date
    2017-10-26
  • 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
    It was recently identified that some vysis paraffin pretreatment reagent kits may have been distributed with an incorrect lot number printed on the packaging labeling. the kit lot number appears in three places on the vysis paraffin pretreatment reagent kits: 1. the abbott molecular certificate of analysis that is packed within each kit 2. the label which is placed on the kit carton and 3. the label which is placed on the outer sleeve that goes over the kit carton. the correct lot number is 2087c172 and it is correctly printed on the certificate of analysis that is packaged within each kit. although unlikely an incorrect lot number (2347c384) may have been printed on the kit carton label and/or on the outer sleeve label.

Device

VYSIS PARAFFIN PRETREATMENT KIT
  • Model / Serial
    Model Catalog: 02J02-032 (Lot serial: 2087C172)
  • Product Description
    VYSIS PARAFFIN PRETREATMENT KIT
  • Manufacturer
    INTER MEDICO

Manufacturer

INTER MEDICO
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Inter Medico
  • Source
    HC