Events

Avis De Sécurité sur cobas u

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
    With this notification we would like to inform you about the possible contamination of cuvettes of cobas u cuvette with small plastic particles. when used on cobas u 701 microscopy analyzer, these particles will be recognized as bacteria by the analyzer. hence, a false positive result for the parameter bacteria (bac) is the potential consequence. this can lead to wrong diagnosis of asymptomatic bacteriuria. in the worst case, a treatment decision can be made based on erroneous positive results for bacteria in urine. only lot 16483701 was reported as affected. roche diagnostics received one customer complaint regarding this issue. .

Device

cobas u

Manufacturer

Roche Diagnostics