Events

Recall of BECKMAN COULTER AU2700 IMMUNOCHEMISTRY SYSTEM - BICARBONATE(CO2) 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
    76896
  • Event Risk Class
    III
  • Event Initiated Date
    2012-04-26
  • 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
    Testing has shown that samples with grossly elevated ldh activity (greater than 30 times the upper limit of the reference range) when tested with the worst affected reagents can be falsely elevated by up to 25 mmol/l. this can also cause a slight positive bias in recovery (~ 2 mmol/l) of bicarbonate when the system is calibrated with aqueous calibrators and qc samples or normal patients' samples are run.

Device

BECKMAN COULTER AU2700 IMMUNOCHEMISTRY SYSTEM - BICARBONATE(CO2) ASSAY
  • Model / Serial
    Model Catalog: OSR6137 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OSR6537 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: OSR6237 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    BECKMAN COULTER AU2700 IMMUNOCHEMISTRY SYSTEM - BICARBONATE (CO2) ASSAY
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.