Events

Recall of GENETIC SYSTEMS HBSAG EIA 3.0 KIT (DONOR SCREEING)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD LABORATORIES (CANADA) LTD..

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
    30820
  • Event Risk Class
    III
  • Event Initiated Date
    2009-02-17
  • 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
    Certain tests de la trousse gs hbsag eia 3.0 ont ete rejetes lors des etudes de stabilite en temps reel:la densite optique du controle positif de niveau "eleve" etait moindre que la limite inferieure acceptable.

Device

GENETIC SYSTEMS HBSAG EIA 3.0 KIT (DONOR SCREEING)
  • Model / Serial
    Model Catalog: 32591 (Lot serial: 179CCC); Model Catalog: 32591 (Lot serial: 235CCC); Model Catalog: 32591 (Lot serial: 164CCC)
  • Product Description
    GS HBsAg EIA 3.0
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.