Events

Recall of ID-DIAPANEL P

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
    26453
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-05
  • 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
    Diapanel et diapanel p contiennent des hematies de phenotypes connus servant a l'identification des anticorps dans les epreuves serologiques en immunohematologie. on a releve une erreur typographique sur le profil phenonotypique fourni avec le panel regulier et celui traite a la papaine. diamed a ete informe par un client ayant teste un patient ayant developpe un anti-kp(a) et dont la cellule numero 7 n'etait pas positive. il a ete confirme que le donneur 890147 n'etait pas kp(a+).

Device

ID-DIAPANEL P
  • Model / Serial
    Model Catalog: 004214 (Lot serial: 45171.85.1); Model Catalog: 004114 (Lot serial: 45161.85.1)
  • Product Description
    ID-DIAPANEL P;ID-DIAPANEL
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.