Events

Recall of Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD) Access 2, Access 2, Re-manufactured and the UniCel DxC 600i SYNCHRON Access Clinical Systems

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-2017-RN-00369-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00369-1
  • 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
    It has been determined that a circuit board that controls motor functions in specific instrument systems can affect device positioning on the pipettor and incubator belt while the instrument is running. users may experience the following errors that may cause a delay in the reporting of patient results: - an incubator belt motion error which can result in the instrument going into the not ready mode and cancellation of all in-process tests; and/or - z pipettor motion errors which can result in cancelled tests.In the worst case scenario, the potential harm would be a delay in patient diagnosis and/or treatment, with a potential worst case severity of permanent injury. the probability of harm for this event is unlikely.
  • Action
    Beckman Coulter (BC) is advising users to adhere to the following interim instructions. If you experience: - z pipettor motion errors, to re-run any cancelled tests; and/or - incubator belt motion errors. please review the associated event on the ‘Event Log’ screen and follow the troubleshooting instructions provided. Users are further advised that they will be contacted by their BC service representative to schedule a visit to replace the circuit board on their instruments as a permanent fix.

Device

Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD) Access 2, Acc...
  • Model / Serial
    Access 2 Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD)Access 2, Access 2, Re-manufactured and the UniCel DxC 600i SYNCHRON Access Clinical SystemsReference Numbers: 81600N, 386220, A25637, A25638 Multiple Instrument Serial NumbersARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd