Events

Recall of ELECSYS FREE T4

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

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
    71094
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-22
  • 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
    During recent internal on-board stability studies decreasing calibrator signals were observed for elecsys ft4 reagent kits when stored more than 3 weeks on-board the elecsys systems (cobas e 411 and cobas e 601/602).

Device

ELECSYS FREE T4
  • Model / Serial
    Model Catalog: 11731297122 (Lot serial: 16519303 16519304); Model Catalog: 11731297122 (Lot serial: 16649801 16649803); Model Catalog: 11731297122 (Lot serial: 16763501 16763502); Model Catalog: 11731297122 (Lot serial: 16763503); Model Catalog: 11731297122 (Lot serial: 16845401 16845403)
  • Product Description
    Elecsys FT4
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC