Events

Avis De Sécurité sur Combur-Test / Chemstrip / ChoiceLine 10 test

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 Diagnostics.

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 we have identified an error in some languages in the method sheets of some urine test strips providing a test field for nitrite (nit). the error appears in the sections “limitations - interferences” or section / table “accuracy” in different language versions however not all languages are always affected. specifics germs which are clearly gram-negative are falsely classified as gram-positive. chemistry of strip measurement system is not affected. no risk of erroneous measurement is related. .

Device

Combur-Test / Chemstrip / ChoiceLine 10 test

Manufacturer

Roche Diagnostics