Events

Recall of VERIFY CONTROL PLASMAS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX 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
    78607
  • Event Risk Class
    III
  • Event Initiated Date
    2002-04-12
  • 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
    Aptt test was out of specification.The current stability testing of lot 111014 indicates that the reconstituted stability profile has exceeded our performance specification.

Device

VERIFY CONTROL PLASMAS
  • Model / Serial
    Model Catalog: (Lot serial: LOT 111014 MODEL 34124)
  • Product Description
    VERIFY H
  • Manufacturer
    BIOMERIEUX INC.

Manufacturer

BIOMERIEUX INC.