Events

Recall of Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays

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-2014-RN-01350-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01350-1
  • 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
    N-acetyl cysteine (nac), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been recently determined to interfere with the detection of the following analytes on beckman coulter clinical chemistry platforms: enzymatic creatinine, cholesterol, uric acid, lactate, and lipase. nac is an anti-oxidant and can interfere with assays and this may lead to falsely low results and subsequent mistreatment.
  • Action
    The instructions for use will be amended to contain a warning pertaining to patients being treated with N-Acetyl Cysteine (NAC) for a paracetamol overdose may generate false low results for specific tests. This action has been closed-out on 26/08/2016.

Device

Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays
  • Model / Serial
    Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase AssaysEnzymatic Creatinine Reference Number: OSR6X204Cholesterol Reference Number: OSR6X16Uric Acid Reference Number: OSR6X98Lactate Reference Number: OSR6X93Lipase Reference Number: OSR6X30All lot numbers affected ARTG Number: 200018In Vitro Diagnostic Medical Devices (IVDs)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd