Events

Recall of Beckman HDL Cholesterol

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    20115
  • Event Initiated Date
    2016-05-06
  • 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
    There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results., metamizole (dipyrone) has been identified as an interferent which may cause false low results in the following assays: cholesterol osr6x16, triglyceride osr6x118, uric acid osr6x98, lactate osr6x93, enzymatic creatinine osr6x204 and lipase osr6x30. this is a previously undocumented interferent., these interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter.
  • Action
    Instructions for use to be updated

Device

Beckman HDL Cholesterol

Manufacturer

manufacturer #1479