Events

Avis De Sécurité sur cobas u 601 / cobas u 701

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
  • Date
    2017-12-21
  • 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 sample mismatch within one rack. the analyzer may not transport the rack correctly, so that tubes might be detected twice. as a consequence, the same tube barcode label is read twice and the last tube barcode label is interpreted as the rack id. hence, a sample mismatch is possible between samples processed on the same rack, because the tubes are pipetted in the order given by the rack position and the test result assigned to the wrong sample id. the sample id read twice is thus listed in duplicate in the sample order list and test result list. the orders/test results have different rack ids. the consecutive sample id’s are also affected, since they are listed only once. as a consequence, they have an incorrect rack position displayed. .

Device

cobas u 601 / cobas u 701

Manufacturer

Roche Diagnostics