Events

Recall of SYNCHRON LX SYSTEMS IG-A 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
    14966
  • Event Risk Class
    II
  • Event Initiated Date
    2010-06-29
  • 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
    Ig-a reagent lots m812614 and m902345 contain an unidentified cross reacting antibody that may yield falsely high ig-a results in survey samples for immunoglobulins which are formulated with ig-m monoclonal antibodies.

Device

SYNCHRON LX SYSTEMS IG-A REAGENT
  • Model / Serial
    Model Catalog: 467920 (Lot serial: Lot Number M182164); Model Catalog: 467920 (Lot serial: Lot Number M902345); Model Catalog: 467920 (Lot serial: Lot Number M909608); Model Catalog: 467920 (Lot serial: Lot Number M904324); Model Catalog: 467920 (Lot serial: Lot Number M810152); Model Catalog: 467920 (Lot serial: Lot Number M808240)
  • Product Description
    SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.