Events

Recall of Synchron Systems Salicylate Reagent. 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-2017-RN-00844-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00844-1
  • 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
    As a result of internal investigations, beckman coulter has identified temozolomide, an oral antineoplastic drug used to treat certain types of brain cancers, as a potential source of interference with synchron salicylate reagent (saly).- temozolomide concentrations of 40 mg/l or greater may cause a negative bias in salicylate test results of up to -22%.- the half-life of temozolomide is approximately 1.8 hours, with the active half-life of the metabolite being slightly longer. the probability of an erroneous patient result will be dependent upon the times of administration and dosages of both drugs, salicylate & temozolomide. longer intervals of time between administration of the drugs and the testing will reduce the probability and severity of harm. lower doses of either drug will also reduce the severity of harm. the worst case scenario only occurs if a patient that is overdosed on salicylates is tested within a short period of time after receiving a high dose of temozolomide.
  • Action
    No immediate action is required by laboratories other than being aware of this issue as the IFU is being updated. Beckman Coulter is not recommending a retrospective review of prior test results.

Device

Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD)Reference Number: 378194All LotsARTG Number: 185654
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd