Events

Recall of BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM- UREA NITROGEN (BUN) 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
    84322
  • Event Risk Class
    III
  • Event Initiated Date
    2012-03-07
  • 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
    Some customers may see an increase in calibration factor for urea nitrogen reagent osr6134 and osr6234 on the au480/au680 analyzers which in turn may lead to calibration failures that could delay quality control or patient sample analysis.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM- UREA NITROGEN (BUN) ASSAY
  • Model / Serial
    Model Catalog: OSR6234 (Lot serial: ALL LOTS); Model Catalog: OSR6134 (Lot serial: ALL LOTS)
  • Product Description
    UREA NITROGEN (FOR THE AU480/AU680 ANALYZERS ONLY)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.