Events

Recall of Roche Accu-Chek Inform 11 Base Unit and Handheld Base Unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    20444
  • Event Initiated Date
    2016-07-28
  • 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
    Some accu-chek® inform ii base units (bu) and handheld base units might produce transmission errors in the form of data loss in the usb communication between the meter and the dms; for example, cobas it 1000 or any other 3rd party software. this could happen in rare cases when the base unit is connected via usb connection to a pc. this may be indicated by numerous (nonspecific) error messages sent from the meter to the dms in the form of unexpected software failure 11800 events.
  • Action
    Software to be upgraded

Device

Roche Accu-Chek Inform 11 Base Unit and Handheld Base Unit
  • Model / Serial
    Model: 05060290001 and 04805658001, Affected: , Software version: 3.00.00
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479