Events

Recall of AMH Gen II ELISA 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-2013-RN-00613-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00613-1
  • 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
    This is a follow up to the urgent recall for product correction (tga reference: rc-2012-rn-01227-1) issued in december 2012. beckman coulter has confirmed that undiluted patient samples measured with the amh gen ii elisa kit may generate results that are lower than expected, due to interference from complement. the previous communication indicated that diluted test results may exceed their true value and that using undiluted samples did not impact test results.
  • Action
    Beckman Coulter is asking users to discontinue use of all product with lot numbers less than or equal to 326119. It is recommended that all previous test results are evaluated that were not consistent with the patient's clinical presentation. Beckman Coulter are recommending that clinicians are notified of potential erroneous results at the discretion of the Laboratory Director. Update: Beckman Coulter has provided their customer's with updated package insert and instructions to eliminate the complement interference. The updated information includes steps to be taken to determine if the interference issue affects the product and an updated IFU to follow should the assay kit be affected.

Device

AMH Gen II ELISA Kit. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    AMH Gen II ELISA Kit. An in vitro diagnostic medical device (IVD). Part number: A79765All lot numbers before and including 326119
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd