Events

Avis De Sécurité sur UniCel DxH 800

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 Beckman Coulter, Inc. .

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
    2016-08-08
  • 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
    Results from a patient control sample could be misidentified by being associated with a pending test order for a patient sample already on the worklist when the following sequence of events occurs:  the primary identifier is tube position id.  a patient control file is setup for id xxxxx, and a pending test order for a patient sample id xxxxx is subsequently added to the worklist.  the patient control sample is analyzed using cassette presentation, but that tube does not contain a barcode-labeled specimen id or the label cannot be read. .

Device

UniCel DxH 800

Manufacturer

Beckman Coulter, Inc.