Events

Recall of TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - TANGO INFINITY

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
    22719
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-18
  • 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
    A microplate was inadvertantly placed in the loading station while in function displacing the previous plate. a erroneous test result was attributed to the placement of the wrong microplate.

Device

TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - TANGO INFINITY
  • Model / Serial
    Model Catalog: 850000010 (Lot serial: All lots.)
  • Product Description
    TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - Tango Infinity
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.