Events

Recall of COBAS H 232 INSTRUMENTS

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
    18530
  • Event Risk Class
    II
  • Event Initiated Date
    2016-04-26
  • 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
    Contamintaion of the mirror from the optical system can lead to false positive signals in the early phase of measurement which can lead to the following failure pattern on a cobas h 232: "tnt elevated" displayed during the measurement but the final results is trop t (less than) 50ng/l iqc level-ii fails e-402 during a measurement.

Device

COBAS H 232 INSTRUMENTS
  • Model / Serial
    Model Catalog: 04901142190 (Lot serial: More then 100 contact manuf.)
  • Product Description
    COBAS H 232 INSTRUMENTS
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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