Events

Recall of IMMAGE 800 IMMUNOCHEMISTRY SYSTEM

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
    119743
  • Event Risk Class
    III
  • Event Initiated Date
    2008-02-04
  • 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
    Immage chemistry protocol diskette version aj: to add new assay ccrp to immage 800 chemistry menu. when loaded on new immage 800 system udr function unavailable aag immage assay missing from diskette.

Device

IMMAGE 800 IMMUNOCHEMISTRY SYSTEM
  • Model / Serial
    Model Catalog: PROTOCOL DISKETTE V AJ (Lot serial: No Serial numbers given.); Model Catalog: PROTOCOL DISKETTE V AJ (Lot serial: no control numbers given)
  • Product Description
    IMMAGE Chemistry Protocol Diskette AJ
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.