Events

Recall of ANTI-LEB (MONOCLONAL)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DOMINION BIOLOGICALS 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
    71581
  • Event Risk Class
    II
  • Event Initiated Date
    2011-06-20
  • 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
    Immucor has received and confirmed reports of this reagent lot demonstrating weak reactivity with rare examples of le(a+b-) red blood cells. due to the unexpected reactivity this lot has demonstrated immucor has decided to withdraw this lot from the market. this issue was first reported/discovered on 2011-06-01.

Device

ANTI-LEB (MONOCLONAL)
  • Model / Serial
    Model Catalog: 0004864 (Lot serial: 992006)
  • Product Description
    Gamma-Clone Anti-Leb(Murine Monoclonal)
  • Manufacturer
    DOMINION BIOLOGICALS LTD

Manufacturer

DOMINION BIOLOGICALS LTD
  • Manufacturer Address
    DARTMOUTH
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC