Events

Recall of Liaison C-Peptid Assay. 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 DiaSorin 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-2017-RN-00323-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00323-1
  • 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
    A recent testing of liaison c-peptid assay by diasorin has highlighted the issue of cross reactivity with human proinsulin. this cross reactivity occurs in 100% of the tested samples and results in an increased c-peptide concentration in all samples tested, across all populations. for normal patients, the risk of falsely elevated results is rare, since the concentration of proinsulin in healthy fasting people is at least 100 times lower than the c-peptide concentration and therefore has only minimal effect on the results determined with the assay. patient populations of highest risk for falsely apparently elevated assay results are patients with insulin processing defects, renal malfunction, insulinoma or similar conditions.
  • Action
    DiaSorin is requesting users to confirm receipt of the “Urgent Recall for Product Correction” notification by completing the response section and returning it to DiaSorin. Users are advised of the possibility of further action pending TGA's receipt of additional information.

Device

Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Liaison C-Peptid Assay. An in vitro diagnostic medical device (IVD).Part Number: 316171All LotsARTG Number: 189435
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd