Events

Retiro De Equipo O Alerta De Seguridad para Reagents for analyzers modular immunochemical and biochemical ARCHITECT: reagent kit ARCHITECT T3 General / ARCHITECT Total T3 Reagent Kit (Lot: 38901UI00, 38901UI01)

Según Ministry of Health of the Republic of Belarus, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Belarus que fue producido por Diagnostics Division, Ireland.

¿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
    Recall / Safety alert
  • Número del evento
    ИМ-7.97735
  • Fecha
    2014-09-23
  • País del evento
    Belarus
  • Fuente del evento
    MHRB
  • URL de la fuente del evento
    https://www.rceth.by/ru/Safety/MedSafety
  • Notas / Alertas
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Notas adicionales en la data
  • Causa
    Abbott decided to report the recall of the architect total t3 reagent kit (lot: 38901ui00, 38901ui01), and provide instructions on the actions that should be taken. the company has determined that 17% of the reagents of the two lots listed above may show lower relative light units (rlu) than expected, which in turn may affect the results of patient analyzes and make the indicators higher than expected. if you use or have reagent kits from lots 38901ui00 or 38901ui01, you should: stop using and destroy all remaining reagent kits according to your laboratory procedures; review previously obtained patient test results.

Device

Reagents for analyzers modular immunochemical and biochemical ARCHITECT: reagent kit ARCHITECT T3...

Manufacturer

Diagnostics Division, Ireland
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRB