Events

Recall of VARIANT II HEMOGLOBIN TESTING SYSTEM - BETA THALASSEMIA SHORT PROGRAM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD LABORATORIES 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
    22217
  • Event Risk Class
    III
  • Event Initiated Date
    2014-04-25
  • 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
    Identification d'un probleme au niveau des solutions tampons qui altere la quantification du pic de l'hemoglobine f. la calibration et le controle de qualite pourraient ne pas respecter les normes avec le lot vise de ce rappel.

Device

VARIANT II HEMOGLOBIN TESTING SYSTEM - BETA THALASSEMIA SHORT PROGRAM
  • Model / Serial
    Model Catalog: 270-2154 (Lot serial: #cat 270-2154 64004750); Model Catalog: 270-2103 (Lot serial: #cat 270-2154 64004750); Model Catalog: 270-2154 (Lot serial: #cat 270-2154 64005207); Model Catalog: 270-2103 (Lot serial: #cat 270-2154 64005207); Model Catalog: 270-2154 (Lot serial: #cat 270-2103 64005302); Model Catalog: 270-2103 (Lot serial: #cat 270-2103 64005302)
  • Product Description
    Variant II Beta-Thalassemia Short Program
  • Manufacturer
    BIO-RAD LABORATORIES INC.

Manufacturer

BIO-RAD LABORATORIES INC.