Events

Recall of Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. 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-2015-RN-01017-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-10-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01017-1
  • 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
    Beckman coulter has confirmed that n-acetyl cysteine (nac) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations with assays using the trinder chemical pathways; enzymatic creatinine (cr-e) and uric acid (uric). nac interference may lead to falsely low results for uric acid and creatinine in patients who are concurrently being treated for acetaminophen overdose with nac.
  • Action
    Beckman Coulter is amending the INTERFERENCES section of the Chemistry Information Sheets to include N-Actel Cysteine. There is no requirement to review previously generated results. This action has been closed-out on 04/03/2016.

Device

Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnosti...
  • Model / Serial
    Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnostic medical device (IVD)Product Codes: A60298 (CR-E), All Lot Numbers are affectedARTG Numbers: 213984 and 222819
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd