Events

Recall of TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - BIOTESTCELL 1 & 2

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
    28539
  • Event Risk Class
    II
  • Event Initiated Date
    2017-09-15
  • 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
    Biotest cell 1 et 2 contiennent des hematies de phenotypes connus servant au depistage des anticorps lors des epreuves serologiques en immunohematologie. dans un avis transmis le 11 septembre bio-rad medical diagnostics gmbh ont rapporte que les hematies du lot 8731011-00 contenues dans le flacon 1 (donneur no. 100136) ont ete declarees comme etant du phenotype fy(a+ b-) alors que le phenotype correct est fy(a+ b+ w).

Device

TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - BIOTESTCELL 1 & 2
  • Model / Serial
    Model Catalog: 816 014 100 (Lot serial: 8731011-00)
  • Product Description
    TANGO AUTOMATED BLOOD BANK ANALYZER SYSTEM - BIOT
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.