Events

Recall of ELECSYS TSH (THYROID STIMULATING HORMONE)

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

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
    102921
  • Event Risk Class
    III
  • Event Initiated Date
    2011-11-19
  • 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
    The manufacturer has identified during internal investigation related to a customer complaint a new interference for igg and igm on the elecsys tsh ft4 and ft3 assays.

Device

ELECSYS TSH (THYROID STIMULATING HORMONE)
  • Model / Serial
    Model Catalog: 11731459122 (Lot serial: STARTING FROM LOT 165385-04); Model Catalog: 03051986190 (Lot serial: STARTING FROM LOT 164774-03); Model Catalog: 11731297122 (Lot serial: STARTING FROM LOT 165193-04)
  • Product Description
    ELECSYS TSH
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH

Manufacturer

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