Events

Recall of OPTI Blood Gas analysers - 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 Helena Laboratories 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-00367-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00367-1
  • 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
    Opti medical has identified that when so2 is below 80%, the bias on the thb is outside of their claims for measurement accuracy. the calculated parameters, hct and o2 (ct) are also significantly affected by the thb issue. the root cause is due to a shift in the wavelength of one of the lasers used to measure thb and so2. the shift occurred when opti switched suppliers of the laser.
  • Action
    End users are advised not to report tHb results from the affected device or use an alternative method to measure tHb when SO2 is below 80%. The Hct and O2(ct) calculated parameters should also not be reported when SO2 is below 80%. Users are strongly recommend to review patient tHb results when SO2 results were below 80% to determine if any adverse events have occurred. A software update is being developed to correct the issue. This action has been closed-out on 09/08/2016.

Device

OPTI Blood Gas analysers - An in vitro diagnostic medical device (IVD)
  • Model / Serial
    OPTI Blood Gas analysers - An in vitro diagnostic medical device (IVD)- All OPTI CCA-TS2 analyzers (GD7046)- OPTI CCA-TS analyzers (GD7013) with serial numbers 2700 and above - OPTI CCA analyzers (GD7045) with serial numbers 8056 and above- OPTI R analyzers (GD7031) with serial numbers 1334 and aboveARTG Number: 227530
  • Manufacturer
    Helena Laboratories Australia Pty Ltd

Manufacturer

Helena Laboratories Australia Pty Ltd