Events

Recall of Beckman Coulter Anti-Mullerian Hormone (AMH) Gen II ELISA

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Beckman Coulter Inc.

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
    14828
  • Event Initiated Date
    2013-06-20
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • Reason
    Undiluted patient samples masured with the amh gen ii elisa kit may generate results that are lower than expected, due to interference from complement. this may lead to test results for neat amh patients samples being lower than expected.
  • Action
    Product to be destroyed

Device

Beckman Coulter Anti-Mullerian Hormone (AMH) Gen II ELISA
  • Model / Serial
    Model: Part Number: A79765, Affected: All lots before and including 326119
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc