Events

Field Safety Notices about VITROS® Systems using Software Version 3.2.2 and Below

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Ortho Clinical Diagnostics.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    As part of a field safety corrective action, ortho clinical diagnostics (ortho) initiated this urgent field safety notice due to a vitros system software timing anomaly that could cause two different sample metering scenarios that may lead to erroneous results. scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) causing sample b to be contaminated and diluted by sample a. .

Device

VITROS® Systems using Software Version 3.2.2 and Below

Manufacturer

Ortho Clinical Diagnostics