Events

Recall of DURACLONE B27 REAGENT KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    20667
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-03
  • 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
    Beckman coulter has identified that the reagent lot identified above was inadvertently released to market despite not meeting its full product specification. the hla-b27 median fluorescence intensity (mdfi) of this lot is higher than lots meeting the product specification which may lead to: (1) an indicated result in the indeterminate zone when the true result is in the negative range or (2) an indicated result in the positive range when the true result is in the indeterminate zone. the issue was discovered on 2016 march 21 during periodic review of our batch records. there has been no report of death or injury related to this defect.

Device

DURACLONE B27 REAGENT KIT

Manufacturer

BECKMAN COULTER CANADA L.P.