Events

Recall of Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate 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-2017-RN-00480-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00480-1
  • 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 identified the drugs metamizole (dipyrone), sulfasalazine and sulfapyridine as potential sources of interference when using synchron systems cholesterol, creatinine, hdl cholesterol, lactate, triglyceride, uric acid and salicylate reagents. with the administration of these drugs, the effects to patient analytes are:- metamizole (dipyrone) – may generate false low cholesterol, enzymatic creatinine, hdl cholesterol, lactate, triglycerides and uric acid results.- sulfasalazine – may generate false high salicylate results.- sulfapyridine – may generate false low salicylate results.Information regarding interference with these drugs will be added to the chemistry information sheets (cis) for the respective products.
  • Action
    Beckman Coulter is advising users of additions to the Interferences section of the respective Chemistry Information Sheets (CIS), as follows: - For CHOL, CR-E, HDL, LACT, TG, TG-B and URIC*: Venipuncture immediately after or during the administration of Metamizole (Dipyrone) may lead to falsely low results for [analyte name*]. Venipuncture should be performed prior to the administration of Metamizole. -For SALY: Patients treated with Sulfasalazine may generate a false high result for Salicylate. Patients treated with Sulfapyridine may generate a false low result for Salicylate. The CIS will be updated on the Beckman Coulter website's Technical Documents webpage.

Device

Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and S...
  • Model / Serial
    Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents. An in vitro diagnostic medical device (IVD)Reference Numbers:467825 - Cholesterol (CHOL)A60298 - Enzymatic Creatinine (CR-E) A15625 - HDL Cholesterol (HDL)A95550 - Lactate (LACT)445850 - Triglyceride (TG and TG-B)442785 - Uric Acid (URIC)378194 - Salicylate (SALY)All LotsARTG Number: 185654
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd