Events

Recall of (1) Cobas 8000 e series (2) Cobas 8000

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by Roche Diagnostics Corporation.

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
    2-8165
  • Date
    2018-05-01
  • Event Country
    Japan
  • Event Source
    PMDAJ
  • Event Source URL
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=2-8165
  • Notes / Alerts
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, 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 Japan.
  • Extra notes in the data

Device

(1) Cobas 8000 e series (2) Cobas 8000
  • Model / Serial
  • Product Description
    Discrete method Clinical chemistry automatic analyzer, ion selectivity analyzer, immunoluminescence measuring instrument
  • Manufacturer
    Roche Diagnostics Corporation

Manufacturer

Roche Diagnostics Corporation