Events

Recall of VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). 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-2016-RN-01627-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01627-1
  • 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 urine protein results using vitros upro slides. the following observations were made when using vitros upro slides:-1. variability gen to gen for patient samples. impact to results: magnitude of bias is dependent upon the gen;-2. variability in results for random and 24-hour urine samples with low specific gravity. impact to results: unexpected increase in the number of results exceeding the reference intervals for random and 24-hour urine samples.; and-3. negatively biased results. impact to results: negatively biased results versus the ortho pyrogallol red comparative method.Ortho is providing users with the results of their internal testing that details the levels of bias observed for each of the scenarios above.Gens 12-18 are affected, however the gen 12 and 13 product have expired.
  • Action
    Ortho is advising users to immediately discontinue using and discard all VITROS UPRO Slides remaining in their inventory. Ortho will credit accounts for any discarded VITROS UPRO Slides and VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Any concerns users may have regarding previously reported urine protein results should be discussed with the Laboratory Medical Director to determine the appropriate course of action. As Ortho is unable to provide replacement VITROS UPRO Slides at present, they recommend laboratories use an alternative method until further notice by Ortho of future product availability.

Device

VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5...
  • Model / Serial
    VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). An in vitro diagnostic medical device (IVD).VITROS UPRO Slides GENs 14, 15, 16, 17 & 18Product Code: 6800120Expiry Date range: 1 Jan 2017 to 1 May 2018ARTG Number: 232251
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd