Events

Recall of IMMAGE IMMUNOCHEMISTRY SYSTEM AAT ALPHA-1-ANTITRYPSIN 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
    74220
  • Event Risk Class
    III
  • Event Initiated Date
    2012-05-17
  • 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
    Linearity failure in samples with low concentrations of alpha1-antitrypsin (aat) when analyzed using the affected aat lots. samples with target values below 80 mg/dl may recover up to 20% low when reported from the initial 1:216 dilution.

Device

IMMAGE IMMUNOCHEMISTRY SYSTEM AAT ALPHA-1-ANTITRYPSIN REAGENT
  • Model / Serial
    Model Catalog: 447740 (Lot serial: M105003); Model Catalog: 447740 (Lot serial: M010527); Model Catalog: 447740 (Lot serial: M008203)
  • Product Description
    IMMAGE IMMUNOCHEMISTRY SYSTEMS ALPHA1-ANTITRYPSIN (AAT) REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.