Events

Recall of IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). 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-2016-RN-00437-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00437-1
  • 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
    The manufacturer, iris international has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes.
  • Action
    Beckman Coulter is advising users to ensure the directions for handling and storage of the control material as per the IFU are followed to prevent premature degradation of the control material. Users are advised to discard the bottle if the QC fails and use alternative bottles in the kit. If the problem persists, request a product replacement from Beckman Coulter. This action has been closed-out on 03/02/2017.

Device

IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin)....
  • Model / Serial
    IRISpec CA/CB/CC and IRISpec CA/CB Control Kits (quality control for the detection of Bilirubin). An in vitro diagnostic medical device (IVD)Reference Number: 800-7211Lot Numbers: 336-15, 343-15 (Exp April 2016) Lot Numbers: 004-16,006-16,019-16,021-16,182-15 (Exp May 2016)Reference Number: 800-7702Lot Numbers: 313-15, 336-15 (Exp April 2016) Lot Numbers: 004-16 (Exp May 2016)Reference Number: 800-7211Lot Number: 309-15 (Exp April 2016)ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd