Events

Recall of VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems)

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-00941-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00941-1
  • 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 determined that negatively biased results may occur when processing citrate plasma samples using vitros chemistry products phyt slides. as a result, citrate plasma is being removed as a recommended specimen type for vitros phyt slides. internal testing by ortho confirmed negatively biased patient results using vitros phty slides for citrate plasma samples. the majority of the bias may be attributed to the dilution effect of the liquid anticoagulant in the citrate plasma tubes with the sample. serum and/or heparin plasma samples obtained from the same patients did not exhibit biased results. the average negative bias observed using citrate plasma samples when compared to serum samples is approximately 18% across the phyt reportable measuring range of 3.00–40.00 µg/ml (11.88–158.40 µmol/l).
  • Action
    Citrate plasma is being removed as a recommended specimen type for VITROS PHYT Slides. 1. Immediately discontinue using citrate plasma samples for VITROS PHYT Slides: 2. Retain this notification as verification of the revised instructions. 3. Notify laboratory and medical staff of this change. 4. Continue using heparin plasma or serum samples to process VITROS PHYT Slides. 5. Complete the supplied Customer Acknowledgement form of Receipt and return. 6. Post the notification by each VITROS System or with the user documentation. 7. Forward the notification if you have distributed these products outside of your facility.

Device

VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with ...
  • Model / Serial
    VITROS Chemistry Products PHYT Slides. An in vitro diagnostic medical device (IVD)(utilised with VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and VITROS 5600 Integrated Systems)Unique Identifier Number: 10758750004690Product Code: 8298671Affects expired, current (in date) and future products GENsARTG Number: 245278
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd