Events

Avis De Sécurité sur Elecsys 2010 analyzer

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 Hitachi High Technologies Corporation (HHT).

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
    We regret to inform you that in very rare cases a software (sw) malfunction in the sample&control datafile can occur which may lead to a potential data mismatch. this sw malfunction only occurs: ∑ when the “sample data clear” function is not performed daily as indicated in the operator’s manual, and ∑ when the sample&control datafile of the elecsys 2010 analyzer is filled with > 600 records. roche has received no customer complaints for this issue. this error only occurs if deletion of documented results or samples is not performed as pre or post operation function. .

Device

Elecsys 2010 analyzer

Manufacturer

Hitachi High Technologies Corporation (HHT)