Events

Recall of VITROS Chemistry Products VANC Reagent. 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 Ortho-Clinical Diagnostics 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-00302-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00302-1
  • 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
    Ortho clinical diagnostics (ortho) has identified the potential for biased results generated using vitros vanc reagent. this can occur after the reagent packs are loaded onto the analyser and stored within the on-analyser stability date. some customers observed a positive drift of >2 standard deviation (sd) in quality control results when using vitros tdm performance verifiers (levels i, ii & iii). ortho's testing confirmed a positive drift in patient and quality control results within a reagent pack in as few as approximately 7 hours. for the affected lots, results may begin to show a drift as soon as packs are loaded onto the system. the magnitude of positive drift for the affected reagent packs is approximately 8-15% across the vanc reportable measuring range of 5.00–50.00 ìg/ml (3.35–33.50 (ìmol/l).
  • Action
    Users are advised to immediately discontinue using and discard all remaining inventory of VITROS VANC Reagent Packs for the affected lots listed above. Discuss any concerns users may have regarding previously reported results with their Laboratory Medical Director to determine the appropriate course of action. If users do not have an alternate lot in their inventory and have an urgent need to continue testing Vancomycin, they are advised to use the current lot provided that they perform quality control testing with every sample batch (i.e., 1 or more patient samples). Ortho recommends the following: - Run QC fluids prior to and following each sample batch. (Use a minimum of one control fluid at the beginning and end of each sample batch) - Ensure QC results are within acceptable limits prior to releasing sample results until replacement product arrives.

Device

VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    VITROS Chemistry Products VANC Reagent. An in vitro diagnostic medical device (IVD).Product Code: 6801709Lot Numbers: 31-5407 (Exp. 23 May 2017), 31-5474 (Exp. 4 July 2017) , 31-5506 (Exp. 4 July 2017)ARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd