Events

Recall of AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). 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 Zoll Medical 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-01265-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01265-1
  • 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
    It has been determined that a limited number of avoxmeter 1000e cuvettes have exceeded internal control limits for gap measurement. the gap measurement is incorporated into the pathlength value, which in turn is entered into the settings of avoximeter instruments when a new lot of cuvettes are used to run a test. the pathlength values add an additional degree of accuracy in the total haemoglobin (thb) reported value and those calculations where thb is used as a variable. the pathlength values do not affect %02hb, %cohb or %methb results.The affected avoximeter cuvettes may have a slight upward shift in pathlength that can result in a clinically insignificant corresponding downward shift in thb. in a worst case, this shift may cause the reporting of a thb result approximately 5% lower than the actual thb value (e.G. an actual value of 10 g/dl is reported as 9.5 g/dl). the shift presents a low risk to health in the intended clinical uses associated with the avoximeter system.
  • Action
    Zoll Medical is advising users of the possibility of a downward shift in tHb values with the affected lots.

Device

AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures)...
  • Model / Serial
    AVOXimeter 1000E Cuvettes (used for oximetery assessment during heart catheterisation procedures). An in vitro diagnostic medical device (IVD).Product Code: C100BLot Numbers: 607-108, 607-109, 607-110, 607-111, 607-112, 607-114, 607-115, 607-116, 607-117, 607-118, 607-119, 607-120, 607-122, 607-123, 607-124ARTG Number 262423
  • Manufacturer
    Zoll Medical Australia Pty Ltd

Manufacturer

Zoll Medical Australia Pty Ltd