Events

Recall of BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - ISE REAGENTS

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
    28894
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-09
  • 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
    Recent customer feedback has indicated that in some cases auh1019 ise cleaning solution may not be effectively cleaning au ise systems. this issue may be due to gradual decline in chlorine (sodium hypochlorite) concentration over the shelf life of the product.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - ISE REAGENTS
  • Model / Serial
    Model Catalog: AUH1019 (Lot serial: ALL)
  • Product Description
    AU CHEMISTRY SYSTEMS: ISE CLEANING SOLUTION
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.