Events

Recall of SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) 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
    30568
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-08
  • 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
    As the synchron rf reagent ages it may fail calibration with the condition of "math error" on the calibration report. real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: m802452 m804502 m807345 and m808329. calibration failures occur at 12 months.

Device

SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
  • Model / Serial
    Model Catalog: 475136 (Lot serial: M804502); Model Catalog: 475136 (Lot serial: M807345); Model Catalog: 475136 (Lot serial: M808329); Model Catalog: 475136 (Lot serial: M802452)
  • Product Description
    SYNCHRON RHEUMATOID FACTOR (RF) REAGENT
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.