Events

Alerta De Seguridad para Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number: 80146501834 .. Hazard Class: III. Lots: attached list .. Lot lot affected: 2.555 units .. Number of units distributed: 1.980.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott Ireland Diagnostics Division..

¿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
    2023
  • Fecha
    2016-07-04
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    According to company information: Ask your laboratory to take the Required Measures below to reduce the possibility of incidences of calibration errors. A. Once alternative batch is available, return any remaining stock from the following lots of ARCHITECT STAT High Sensitive Troponin-I reagents. (List not attached notice). B. If your laboratory DOES NOT have a batch of alternative reagent available in stock and has generated a valid calibration curve, immediately request the reagent batch replenishment. Continue to use these batches and follow the QC procedures recommended in the instructions for use. These lots have high potential for calibration failures with continued use. If calibration failures are repeated, they will prevent your lab from generating patient results. Once the replacement reagent lot is received, return any remaining stock from the reagent lots according to your laboratory procedures. C. If your laboratory has a batch of available alternate reagent in stock, continue to use these reagents immediately and begin using the alternate reagent batch. Return any remaining stock of batches of reagents according to your laboratory procedures. Your local Abbott representative can assist you in providing replacement products, financial credit and / or recommended alternative solutions. All future lots will have an appropriate shelf life before delivery. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Field action on reducing the shelf life of selected batches of architect stat high sensitive troponin-i reagents listed in table 1 of the customer release. predictive monitoring of quality assurance of architect stat high sensitive troponin-i reagent lots was initiated after the field action in january - ref .: fa21jan2016 (field action not applicable to brazil for not having a lot distributed in brazil). as a result, abbott has identified a potential for increased calibration failures before the expiration date. the root cause of this situation is under investigation for appropriate long-term corrective action.
  • Acción
    Field Action No. FA21JAN2016 Revision 02, triggered under the responsibility of Abott. Classification of risk: III Classification of the field action: Field action - Change of validity d)

Device

Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott Ireland Diagnostics Division.
  • 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
    ANVSANVISA