Events

Recall of Sysmex XN-550 analyser

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
    21425
  • Event Initiated Date
    2017-05-15
  • 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
    The manufacturer has become aware that potentially inaccurate results could occur from improper mixing of a sample on the sysmex xn-550 automated haematology analyser when both of the following conditions occur:, 1. the sample tube setup is for rbt micro collection tube or sarstedt sample tube, 2. the xn-550 analyser is connected to a host computer and a host communication error occurs during a sampler run.
  • Action
    Instructions for use to be updated

Device

Sysmex XN-550 analyser

Manufacturer

Sysmex Corporation