Events

Recall of VITROS Chemistry 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.

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-2015-RN-00326-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00326-1
  • 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 (ocd) has identified instances where the vitros system allowed urine samples for assays that required acidified pre-treatment to be metered from the same sample container as assays that required no pre-treatment when the sample was programmed. the anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (lis) and the sample program contain assays requiring sample pre-treatment and assays requiring no sample pre-treatment.If this anomaly occurs, it is possible for vitros systems to process urine samples without the proper pre-treatment, potentially leading to biased patient results.
  • Action
    The mitigation to this anomaly is currently under development. OCD will issue a follow up notification upon availability of the software update. OCD is providing users with temporary work around instructions and advising users that for urine samples that require pre-treatment to place each of the pre-treated samples in a separate container and manually program the individual samples. Also, OCD is asking users to discuss concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 04/08/2016.

Device

VITROS Chemistry Systems. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    VITROS Chemistry Systems. An in vitro diagnostic medical device (IVD).VITROS 4600 Chemistry System & VITROS 5600 Integrated System Software Version 3.2 & BelowProduct Codes: 6802445 & 6802413VITROS 5,1 FS Chemistry SystemSoftware Version 2.8 & BelowProduct Codes: 6801375 & 6801890Assay Data Disk (ADD)All DRV versions that support product within expiry datingProduct Code: 6801876ARTG number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics