Events

Recall of BECKMAN COULTER AU IMMUNOCHEMISTRY SYS- RHEUMATOID FACTOR (RF) LATEX ASSAY

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
    21789
  • Event Risk Class
    III
  • Event Initiated Date
    2012-01-09
  • 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
    The stability of the rf latex calibrator odc0028 lot 0034 may be compromised and this lot of product may not meet its specified 13 month shelf-life (eg. results for patients and quality controls may rise to unacceptable levels over the coming months).

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYS- RHEUMATOID FACTOR (RF) LATEX ASSAY
  • Model / Serial
    Model Catalog: ODC0028 (Lot serial: 0034)
  • Product Description
    RF LATEX CALIBRATOR
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.