Events

Recall of Gentian Cystatin C Calibrator Kit. 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-2017-RN-00992-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00992-1
  • 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 gentian has identified an issue with two specific lots of gentian cystatin c calibrator kit (lot 0006 and 0008). the identified lots of calibrators resulted in a high bias when used on a dxc instrument. potential risks associated with the increased bias are an underestimation of the cystatin c value, which again gives an overestimation of gfr. the bias should be detected when using controls for validation of the calibration curve. as a worst case in the event this is not detected by the controls, the bias may be close to 20%.
  • Action
    Beckman Coulter is requesting users: 1. Inspect their stocks and immediately stop using calibrator lots 0006 and 0008; 2. Share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, provide them a copy of this letter; 3. Complete and return the Response Form supplied with the Customer Letter within 10 days as confirmation of receipt of this important communication; and 4. If you have any questions regarding this notice, contact your local Beckman Coulter Representative.

Device

Gentian Cystatin C Calibrator Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Gentian Cystatin C Calibrator Kit. An in vitro diagnostic medical device (IVD)Part number: A52763Kit Lot Numbers: 0006 and 0008ARTG Number: 261302
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd