Events

Recall of Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. 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 Bio-Rad Laboratories 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-2012-RN-01295-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01295-1
  • 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 risk of false negative results being reported in urine samples; the concentration of adrenaline/epinephrine may decrease when analysis time is more than 8 hours. this occurs when the samples are subsequently adjusted to ph 5 to 7 as described in the instructions for use for very acidic samples or samples with low 24-volumes.
  • Action
    The sponsor is providing an update to the Instructions for Use (IFU).

Device

Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagno...
  • Model / Serial
    Urinary Catecholamines by HPLC Reagent Kits, Automated Method on Gilson ASPEC. An in vitro diagnostic medical device (IVD)Catalogue Number: 1955700
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd