Events

Recall of VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER

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
    27964
  • Event Risk Class
    III
  • Event Initiated Date
    2015-08-24
  • 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
    Des plaintes ont ete recues concernant un probleme de deversement de liquide dans la chambre de dilution en raison de la contre-pression accumulee dans ces appareils. si le tuyau d'evacuation du liquide interne ou externe est bouche ou pince la contre-pression s'accumule et peut causer le deversement de liquide dans la chambre de dilution. afin d'eviter une potentielle exposition aux dechets liquides il est important de suivre les instructions et recommandations fournie dans le manuel d'utilisation du manuel d'utilisation.

Device

VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: 2702000 (Lot serial: all); Model Catalog: 2702001 (Lot serial: all); Model Catalog: 270-2600 (Lot serial: all); Model Catalog: 270-2601 (Lot serial: all)
  • Product Description
    VARIANT II HEMOGLOBIN TESTING SYSTEM - ANALYZER
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.