Events

Alerta De Seguridad para ORTHO VISION ANALYZER IDMTS

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Tecan Schweiz Ag || Ortho Clinical Diagnostics.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    A1604-141
  • Número del evento
    2015DM-0012864
  • Fecha
    2016-04-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=148
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    The manufacturer has detected a possible security problem where the software incorrectly interprets for one day the built-in expiration dates of 2016-02-29 and later that are on the labels with code debarras (barcodes) for ortho reagent products, the miscalculation of the date of the expiration of the reagent existed since february 29 and will continue until the end of 2016, leading to potential delays in the processing of the samples.

Device

ORTHO VISION ANALYZER IDMTS
  • Modelo / Serial
    6904577, specific serials with software version 1.2.10 and earlier.
  • Descripción del producto
    ORTHO VISION ANALYZER is a device designed to automate in vitro immunohematological analysis of human blood using the cassette technology ofORTHO BIOVUE SYSTEM. ORTHO VISION ANALYZERautomatizes test processing functions, such as liquid pipetting, reagent handling, incubation, centrifugation, classification and interpretation of reactions and requirements for data management through cassettes and digital image processing.ORTHO VISION ANALYZER It can be used as an independent team or connected to the customer's computer system (LIS).
  • Manufacturer
    Tecan Schweiz Ag || Ortho Clinical Diagnostics

Manufacturer

Tecan Schweiz Ag || Ortho Clinical Diagnostics
  • Source
    NIDFSINVIMA