Events

Recall of Sysmex CS-2100i/ 2000i Systems

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
    13149
  • Event Initiated Date
    2012-07-21
  • 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: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • Reason
    Manufacturer advises that cs-2000i and cs-2100i with software version 00-60 show the phenomenon that certain results with error flags highlighted for review, are automatically validated and sent to the host computer without those flags.
  • Action
    Software to be upgraded

Device

Sysmex CS-2100i/ 2000i Systems
  • Model / Serial
    Model: , Affected: all systems with software versions up to and including SW 00-60
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation