Events

Recall of DUET (SCREENING CELLS I & II)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMMUCOR INC..

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
    17059
  • Event Risk Class
    II
  • 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
    Error in the antigen profile sheet.The red cells of r2r2 17364 were listed as lu(a-).Correct information is lu(a+).

Device

DUET (SCREENING CELLS I & II)
  • Model / Serial
    Model Catalog: (Lot serial: lot 0926/4)
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Manufacturer Address
    HOUSTON
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC