Events

Recall of VITROS Chemistry Products Na+ Slides. 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-2018-RN-00736-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00736-1
  • 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 australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.
  • Action
    Ortho Clinical Diagnostics is advising: For VITROS Na+ Slides, GENs 8 & 13: - Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing. For VITROS Na+ Slides, GENs 14, 16, 17 & 18: - Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing. - It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met: 1. Calibration is successful and Quality Control results are within acceptable limits; and 2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory. If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.

Device

VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)Product Code:8379034Affected Generations: GENs: 8, 13, 14, 16, 17, 18Expiry Dates: 01-Nov-2018 through 01-Nov-2019ARTG Number: 232249(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry electrolyte IVDs)
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd