Events

Avis De Sécurité sur VITEK® 2 Gram-Positive (GP)

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
  • Date
    2017-10-17
  • 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
    Users of the aforementioned test reported atypically negative results for enterococcus casseliflavus atcc® 700327 ™, and the biomerieux manufacturer conducted an internal investigation to confirm that quality control (qc) for the vitek 2 gp id card did indeed produce a negative result for the table in the indicated lot. according to the instruction of vitek 2 gp id, the expected reaction for the o129r strain atcc 700327 is positive. your lab did not receive any of the lots listed below, but the biomerieux manufacturer has taken action and includes, in the scope of this notice, all batches of vitek 2 gp id cards made with the same raw materials as the lots listed below (see appendix b for a full list).

Device

VITEK® 2 Gram-Positive (GP)

Manufacturer

bioMérieux