Events

Recall of PREMIER EHEC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MERIDIAN BIOSCIENCE 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
    105081
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-09
  • 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
    Meridian has received reports from customers that false positive test results have been obtained with some broth samples using lots 608096h219 608096h222 608096h225 and 608096h226. false positive complaints have been neither reported nor confirmed on direct stool specimens. the rate of false-positive results will vary from laboratory to laboratory and may be dependent on the laboratory's test volume. kit lots 608096h222 608096h224 and 608096h226 were not distributed in canada .

Device

PREMIER EHEC
  • Model / Serial
    Model Catalog: 608096 (Lot serial: 608096H226); Model Catalog: 608096 (Lot serial: 608096H225); Model Catalog: 608096 (Lot serial: 608096H222); Model Catalog: 608096 (Lot serial: 608096H219)
  • Product Description
    PREMIER EHEC
  • Manufacturer
    MERIDIAN BIOSCIENCE INC.

Manufacturer

MERIDIAN BIOSCIENCE INC.