Events

Recall of Sysmex CA-600 series system

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
    21572
  • Event Initiated Date
    2017-06-22
  • 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, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Reason
    Under rare circumstances there is a potential that the system might fail to alert the operator about an individual sample id no. assigned to multiple patient measurement results when using the built-in barcode scanner. under very rare circumstances this may lead to an incorrect diagnostic and patient treatment decision due to potential of a mismatched result for the patient.
  • Action
    Manufacturer to issue advice regarding use

Device

Sysmex CA-600 series system
  • Model / Serial
    Model: , Affected: Sysmex CA-620 and Sysmex CA-660
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation