Events

Alerte De Sécurité sur Preanalytical Equipment for Sample Management

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Roche Diagnostics Gmbh.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    I1705-193
  • Numéro de l'événement
    2015DM-0013314
  • Date
    2017-05-30
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=86
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer reports that there is the possibility that non-centrifuged samples are incorrectly identified as "centrifuged", due to the detection of the centrifugation status of the referenced medical device, when subsequently the samples analyzed could give erroneous results and cause delays in their processing.

Device

Preanalytical Equipment for Sample Management
  • Modèle / numéro de série
  • Description du dispositif
    The cobas 8100 preanalytic system and the p512 and p612 models is a modular unit interconnected with each other, for the processing and transport of patient samples in the clinical laboratory. The system has been designed to centrifuge patient samples, remove and insert the stoppers, apply barcode labels and with the pipettor prepare the aliquots from the primary samples. You can sort the samples online or off and temporarily store the samples. The system transports the different individualized samples between the analytical modules for immunology, blood chemistry, hematology, hormones, drugs, urine, coagulation and special for the respective laboratory analysis. The system does not report sample results values, it is not a sample analyzer.
  • Manufacturer
    Roche Diagnostics Gmbh

Manufacturer

Roche Diagnostics Gmbh