Events

Recall of IMMAGE IMMUNOCHEMISTRY SYSTEM IGG IMMUNOGLOBULIN G REAGENT

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
    34787
  • Event Risk Class
    III
  • Event Initiated Date
    2017-02-06
  • 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 igg lot m610132a parameter card barcode does not include the "a" suffix encoded in the barcode. the reagent cartridge barcode needed to pair with the parameter card includes the "a" suffix. lot number mismatch causes a "parameters not found" error upon reagent cartridge barcode read. input of parameters and reagent load is by barcode only. system is not capable of manual entry.

Device

IMMAGE IMMUNOCHEMISTRY SYSTEM IGG IMMUNOGLOBULIN G REAGENT
  • Model / Serial
    Model Catalog: 446400 (Lot serial: M610132A)
  • Product Description
    IMMAGE IMMUNOCHEMISTRY SYSTEMS IMMUNOGLOBULIN G REAGENT (IGG)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.