Events

Recall of Beckman Coulter Cholesterol assay

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
    17907
  • Event Initiated Date
    2014-12-23
  • 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
    N-acetyl cysteine (nac), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been recently determined to interfere with assays for the following analytes: enzymatic creatinine osr6x204, cholesterol osr6x16, uric acid osr6x98, lactate osr6x93, and lipase osr6x30., nac interference may lead to falsely low results.
  • Action
    Instructions for use to be updated

Device

Beckman Coulter Cholesterol assay

Manufacturer

Beckman Coulter Inc