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
    25812
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-08
  • 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
    Il est decrit dans le profil phenotypique des lots de biotestcell-l11 impactes que les cellules contenues dans la fiole numero 10 sont positives pour l'antigene m. suite a une investigation de plainte il a ete confirme que ces cellules etaient m negatives. l'identification d'un anticorps anti-m est impossible avec les deux lots impactes.

Device

BIOTESTCELL -I11
  • Model / Serial
    Model Catalog: 816021100 (Lot serial: 8515011-00); Model Catalog: 816 021 (Lot serial: 2515011-00); Model Catalog: 816021100 (Lot serial: 2515011-00); Model Catalog: 816 021 (Lot serial: 8515011-00)
  • Product Description
    BIOTESTCELL -I11
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.