Events

Avis De Sécurité sur MODULAR ANALYTICS, others

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 Roche.

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
    2017-08-17
  • 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
    We have informed you in the previous version of this document that a sample mismatch may occur (i.E orders are shifted) in the immunochemistry modules (cobas e 602, cobas e 601 and e170 modules) due to a software limitation. based on new information received we would like to give you an update. the sample mismatch is caused by a software limitation and only occurs if the following conditions are simultaneously met (i.E. very rare occurrence):  immunochemistry module (cobas e 602, cobas e 601 and e170 modules) is included in its respective system (cobas 8000 modular analyzer series, cobas 6000 analyzer series, modular analytics, modular analytics evo). .

Device

MODULAR ANALYTICS, others
  • Modèle / numéro de série
  • Manufacturer
    Roche

Manufacturer

Roche