Events

Recall of CellaVision DI-60 version 6.0.1 and 6.0.2

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Sysmex 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
    22936
  • Event Initiated Date
    2018-05-07
  • 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
    A bug has been discovered in versions 6.0.1 and 6.0.2 of cellavision di-60 software where some comments are not sent to lis., the problem occurs only when a specific workflow involving multi-slide is selected as described below:, a)multiple slide workflow is selected (i.E. > 1 slide is analyzed on a sample no.), and, b)operator adds a comment on the last slide in the wbc, rbc or plt comment boxes in the di-60 sw after it has been signed/reported.
  • Action
    Software to be upgraded

Device

CellaVision DI-60 version 6.0.1 and 6.0.2
  • Model / Serial
    Model: All on sw version 6.0.1 and 6.0.2., Affected:
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation