Events

Recall of IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR 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
    80715
  • Event Risk Class
    III
  • Event Initiated Date
    2011-06-03
  • 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
    Beckman coulter has confirmed that for lot numbers m908398 and m911529 of immager immunochemistry systems rheumatoid factor reagent known negative results are being reported as slightly positive (between 20 and 30 iu/ml usually). when tested on other methods or with other lots most of these slightly positive samples read < 20 iu/ml or negative. per the cis 95% of normal healthy individuals who live in southern california should have results less than 20 iu/ml. customers utilizing these lots are reporting patient results in more than 5% of their samples with results greater than 20 iu/ml.

Device

IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
  • Model / Serial
    Model Catalog: 447070 (Lot serial: M908398); Model Catalog: 447070 (Lot serial: M911529)
  • Product Description
    IMMAGE IMMUNOCHEMISTRY SYSTEM RF RHEUMATOID FACTOR REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.