Events

Recall of IRISPEC CA/CB/CC

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
    36558
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-11
  • 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
    Iris international has become aware of an issue in which permature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the irispec ca control may fail for the bilirubin analyte. the laboratory will be unable to process patient samples until qc passes. not all bottles within a specific lot may be affected.

Device

IRISPEC CA/CB/CC
  • Model / Serial
    Model Catalog: 475-1227 (Lot serial: 343-15); Model Catalog: 475-1227 (Lot serial: 336-15); Model Catalog: 475-1227 (Lot serial: 004-16); Model Catalog: 475-1227 (Lot serial: 006-16); Model Catalog: 475-1227 (Lot serial: 019-16); Model Catalog: 475-1227 (Lot serial: 021-16)
  • Product Description
    IRISPEC CA/CB/CC
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.