Events

Alerte De Sécurité sur urine analyzer

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 N/A.

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
  • Numéro de l'événement
    2014DM-0011237 ; 2014DM-0011773
  • Date
    2018-02-07
  • 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=56
  • 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

Device

urine analyzer
  • Modèle / numéro de série
    u601 and u701, specific serials.
  • Description du dispositif
    The urine analyzer cobas u 601 (called the urine analyzer in a generic way) is a fully automated urinalysis system designed for the qualitative quantitative in vitro quantitative determination of urinary analytes, such as PH, leukocytes, nitrites, proteins, glucose, ketones, urobilinogen, bilirubin yerithrocytes, as well as specific density, color and turbidity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by qualified operators in clinical laboratories. The analyzer can process up to 240 samples per hour. It is automated.The team cobas u 701 MICROSCOPY ANALYZER (denominadomicroscopio analyzer) is an orinatotalmente automated microscopy system designed for the quantitative invitro determination of erythrocytes and leukocytes, for the semiquantitative determination of squamous and non-squamous epithelial cells, bacteria and cylindershyaline and for the qualitative determination of pathological cylinders, crystals, yeast, mucus and sperm in the urine. The instrument consists of a microscopy system which increases the urinary sediment of the patients sample and presents them on an LCD screen for reading and review by the laboratory professional. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by operators qualified in clinical laboratories.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA