Events

Recall of AQUIOS CL Flow Cytometry System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Beckman Coulter Inc.

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
    22097
  • Event Initiated Date
    2017-12-05
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    The manufacturer is advising that when aquios cl systems are connected to a laboratory information system (lis), the system may duplicate sample requests leading to sample mis-identification., this is an updated notification in follow-up to the previous communication received (dated 16 october 2017) concerning duplicate sample requests leading to sample mis-identification when using the aquios cl systems connected to a laboratory information system (lis). this important information needs immediate attention. the information replaces the instructions in the original notification dated 16 october 2017.
  • Action
    Manufacturer to issue advice regarding use

Device

AQUIOS CL Flow Cytometry System
  • Model / Serial
    Model: , Affected: software versions (2.0, 2.0.1 and 2.1)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc