Events

Recall of Access AMH QC Kits for use with 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-2016-RN-00859-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00859-1
  • 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 that the quality control (qc) value card includes incorrect standard deviation values for the access amh qc kit, lot 689202. the qc value card for this lot lists the following standard deviation values: qc1 as 0.02, qc2 as 0.11 and qc3 as 0.65. the correct standard deviation values are as follows: qc1 is 0.15, qc2 is 0.76 and qc3 is 2.30. use of this restrictive qc range may result in qc failures but there is no impact to patient results.
  • Action
    Beckman Coulter is advising users to use the correct QC values, as provided, when establishing QC ranges for the affected lot. Users should also confirm that the Access AMH QC assigned mean and standard deviation values are set appropriately per individual laboratory procedures. This action has been closed-out on 20/02/2017.

Device

Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medi...
  • Model / Serial
    Access AMH QC Kits for use with Access Family of Immunoassay Systems. An in vitro diagnostic medical device (IVD).Reference Number: B13129Lot Number: 689202Expiry date: 16 September 2017ARTG Number: 213976
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd