Events

Recall of ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). 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-00758-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00758-1
  • 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
    Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified. there is a possibility that drug interference's from administration of sulfasalazine to patients may generate false low alt results and false low glucose-stat results. sulfapyridine may generate false high glucose-stat results (osr6x40).Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 35% for the low alt control and up to 29% for the high alt control.Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 25% (or 1.3 mmol/l) for the low glucose-stat control and up to 13% (or 1.6mmol/l) for the high glucose-stat control.Interference seen with 300mg/l sulfapyridine showed a positive bias of up to 21% (or 1.1 mmol/l )for the low glucose-stat control and up to 9% or (1.1mmol/l) for the high glucose-stat control.There is no risk to patients however there is the potential for a delay in results.
  • Action
    Beckman Coulter is advising users that the IFU has been updated to include additional warnings in the 'Interfering Substances' section. No retrospective review of results is recommended.

Device

ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnost...
  • Model / Serial
    ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnostic medical device (IVD)Reference numbers: ALT OSR6X07, Glucose-Stat OSR6X40All lots affectedARTG numbers: 200015, 200018
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd