Events

Recall of cobas e411 immunoassay analyser

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Patheon API 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
    21580
  • Event Initiated Date
    2017-06-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    In very rare cases a software malfunction in the sample&control datafile can occur which may lead to a potential data mismatch. this software malfunction only occurs when the "sample data clear" function is not performed daily as indicated in the operator's manual, and when the sample&control datafile is filled with more than 2000 records.
  • Action
    Instructions for use to be updated

Device

cobas e411 immunoassay analyser
  • Model / Serial
    Model: , Affected: All models (Disk and Rack), all software versions.
  • Manufacturer
    Patheon API Inc.

Manufacturer

Patheon API Inc.