Events

Recall of PARAGON ELECTROPHORESIS SYSTEM IFE (IMMUNOFIXATION ELECTROPHORESIS)

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
    107420
  • Event Risk Class
    III
  • Event Initiated Date
    2004-01-28
  • 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
    Some patient sample results may be difficult to interpret due to weaker avidity of ab when using the igg antiserum included in the kits affected. dk.

Device

PARAGON ELECTROPHORESIS SYSTEM IFE (IMMUNOFIXATION ELECTROPHORESIS)
  • Model / Serial
    Model Catalog: (Lot serial: P/N 444970 LOTS M307327-307333); Model Catalog: (Lot serial: P/N 444970 LOT 305176); Model Catalog: (Lot serial: P/N 444970 LOTS M310301-310305); Model Catalog: (Lot serial: P/N 446260 LOT M309039); Model Catalog: (Lot serial: P/N 446360 LOT M308363)
  • Product Description
    PARAGON ELECTROPHORESIS SYSTEM (IFE)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.