Events

Field Safety Notices about VITEK® 2 Compact 15 or VITEK® 2 Compact 30 system

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 bioMérieux.

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
    Customers have reported that some vitek® 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. the issue was reported to occur on vitek® 2 compact 15 and compact 30 systems following a system software update to version 8.01. internal investigation has demonstrated when a card is ejected from a slot number greater that 15/30, respectively, the ejection packet fails to be accepted by the computer, and the card status remains at "preliminary". when the anomaly occurs, data for current and future cards will not be transferred to the computer. the data for the ejected card will be lost. .

Device

VITEK® 2 Compact 15 or VITEK® 2 Compact 30 system

Manufacturer

bioMérieux