Events

Recall of COBAS TAQMAN MTB TEST

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

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
    24297
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-12
  • 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 version 3.0 of the cobas taqman mtb test definition file product 2 in table 1 cat 0557445519 has an incorrect target elbow cutoff of 48 instead of 50. this test definition file tdf is used with the cobas taqman mtb test product 1 in table 1 cat 04803531190 patient.

Device

COBAS TAQMAN MTB TEST
  • Model / Serial
    Model Catalog: 04803531190 (Lot serial: all lots)
  • Product Description
    COBAS TAQMAN MTB TEST
  • Manufacturer
    ROCHE MOLECULAR SYSTEMS INC

Manufacturer

ROCHE MOLECULAR SYSTEMS INC
  • Manufacturer Address
    BRANCHBURG
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC