Events

Recall of Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. 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-2014-RN-00562-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00562-1
  • 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 determined that some ultrasonic transducer kits were potentially assembled with incorrect mounting screws. one of these transducers may have been installed on the system during a recent instrument repair. over time the screws can become loose if a combination of correct and incorrect screws are used and possibly cause incorrect probe wash, splashing in the reaction vessels (rv), incorrect particle suspension in the reagent pack, or incorrect rv mix due to alignment of the probe to wash tower/rv leading to assay imprecision. this may cause erraneous but believable results and/or delay of results due to transducer alignment error.
  • Action
    Users are advised to review historical QC data and System Check results since the transducer was installed for any indication of a potential problem and determine whether a review of patient test results is warranted. A service representative will be contacting users to schedule a service visit to confirm that their transducer is properly installed.

Device

Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagno...
  • Model / Serial
    Ultrasonic Transducer Kits used with the Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd