Events

Recall of Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device

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-2018-RN-00084-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00084-1
  • 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 identified a potential issue with the tip present sensor within the robot of the aliquoter module. there has been one overseas report of a misaligned sensor in an automate system, which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case, the system gave no external sign of a misaligned tip present sensor. there is no impact to the sorter module associated with this issue.
  • Action
    Beckman Coulter will arrange field service engineers to inspect affected devices to inspect the tip present sensor for misalignment. If users suspect or observe unusual contamination of the tip carrier arm whilst performing daily maintenance, as described in the IFU please contact the local Beckman Coulter representative immediately. If this is to occur, it is recommended to discontinue use of the Aliquotter module.

Device

Automate 2550 and 1250 Aliquotter Tip Present Sensor.An in vitro diagnostic medical device

Manufacturer

Beckman Coulter Australia Pty Ltd