Events

Recall of Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit used for determination of G-6-PDH in blood)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Immuno 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-00081-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00081-1
  • 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
    The manufacturer, trinity biotech, has identified a potential for misdiagnosis with lot f117009. an investigation identified that this lot displays a level of accuracy variation outside the historical qc product release process control charts for normal range controls, despite falling within the qc acceptance specification. investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring.
  • Action
    Immuno is advising customers to immediately discontinue use of the affected lot and destroy any remaining product. Laboratories are to consider the need to review results previously generated with the affected lot. Immuno will organise replacement kits.

Device

Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit ...
  • Model / Serial
    Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).(quantitative kit used for determination of G-6-PDH in blood)Product Code: 345ALot Number: F117009Expiry: 4 April 2018ARTG Number: 203621
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA