Events

Recall of Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Beckman Coulter Australia Pty Ltd.

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
    RC-2013-RN-00469-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00469-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Beckman coulter has confirmed that access 2 software version 3.4 has the potential to cause communication errors between the instrument and the console computer that are not recognised by the access 2 system. if this communication error occurs, the system will halt any samples that are in-process and test results will not be imported. the clearing of the communication error cannot be resolved by the customer and the instrument will be inoperable until a service engineer performs a system restore.
  • Action
    If this communication error does occur, immediately contact the Beckman Coulter representative who will perform the necessary procedures to restore the affected system. A Beckman Coulter representative will restore all Access 2 systems to the previous unaffected software version.

Device

Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)Affected serial numbers: 504105 and 800084
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd