Events

Recall of TG GEN.2 (THYROGLOBULIN) ASSAY

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
    21817
  • Event Risk Class
    I
  • Event Initiated Date
    2012-10-17
  • 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
    Is related to a possible increases recovery (positive offset of up to approximately 0.6 ng ml) in patient samples for thyroglobulin tg lot 169346. an elevated tg recovery may put certain patients (that had a total thyroid ablation) at risk of receiving (unnecessary) radio-iodine treatment for recurrent carcinoma or further (unnecessary) surgical intervention.

Device

TG GEN.2 (THYROGLOBULIN) ASSAY
  • Model / Serial
    Model Catalog: 05118921190 (Lot serial: 169346)
  • Product Description
    TG GEN.2 (THYROGLOBULIN) ASSAY
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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