Events

Recall of Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnostic 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-2015-RN-00143-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00143-1
  • 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 is advising the users that it is releasing access 2 system software version 3.4.2 and access 2i (unicel dxc 600i system) software version 6.2.2 to address the reagent pack volume issues notification that was distributed august 13, 2010. the notification discussed the risks associated with assay reagent packs that were loaded incorrectly, or reagent packs that were inappropriately transferred between two systems (pack sharing). with these software versions, the new reagent pack monitoring feature enables the access 2 system pressure monitoring hardware to detect packs with insufficient volume, as well as packs that are improperly loaded or missing.
  • Action
    Beckman Coulter is providing customer-installable 3.4.2 or 6.2.2 software disc along with an information packet that describes the new reagent pack monitoring feature to all customers in Australia. This action has been closed-out on 20/06/2016.

Device

Access 2 Immunoassay Systems, UniCel DxC 600i SYNCHRON Access Clinical System An in vitro diagnos...

Manufacturer

Beckman Coulter Australia Pty Ltd