Events

Avis De Sécurité sur VITEK® 2 Compact 15 or VITEK® 2 Compact 30 system

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par bioMérieux.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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