Events

Recall of BIOTESTCELL -I11

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
    19755
  • Event Risk Class
    I
  • Event Initiated Date
    2014-06-17
  • 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
    L'utilisation du profil phenotypique inclus dans le coffret dans l'evaluation des reactions positives aurait produit des resultats discordants ou ambigus. il existe une possibilite de mal identifier les anticorps anti-jk(b) et -s et des problemes transfusionnels que cela aurait pu causer.

Device

BIOTESTCELL -I11
  • Model / Serial
    Model Catalog: 816021100 (Lot serial: 8421011-00); Model Catalog: 816020100 (Lot serial: 8421011-00)
  • Product Description
    BIOTESTCELL - I11
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.