Events

Recall of Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. 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-2016-RN-00577-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00577-1
  • 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
    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 certain assays. 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 and may result in an error in diagnosis or patient management.No customer complaints have been received for this particular issue.
  • Action
    Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences. A review of previously generated patients results is at the discretion of the Laboratory Director.

Device

Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. A...
  • Model / Serial
    Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic medical device (IVD)Product Codes: OSR6X204, OSR6X16, OSR6X118, OSR6X98, OSR6X93, OSR6X30All lot numbers affectedARTG Numbers: 200018, 200015
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd