Alerta De Seguridad para Commercial Name: PR4100 Microplate Reader. Technical name: Instrument for immunoassays. ANVISA registration number: 80020690326. Class of risk: II. Model Affected: 00 000 000 094196. Serial numbers affected: 1702001988; 1702001989; 1702001995; 1701004076; 1701004078; 1701004079; 1701004087; 1611001407; 1701004096; 1601004139; 1601004146.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bio-Rad Laboratórios Brasil Ltda.; Bio-Rad.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    We recommend not programming your non-Bio-Rad test protocols using 5-parameter curve analysis or, using Marquardt 5-parameter curve analysis, make sure that the standard curve follows a sigmoidal shape (with upper plateau and bottom). As a precautionary measure, the administrator must change the user's password before blocking the user. This will prevent the blocked user from logging in again after the lock. 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 Additional information: - Date of identification of the problem by the company: 12/03/2018 - Date of notification notice to Anvisa: 10/04/2018 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Possible problems with magellan software version 7.0 that runs on the pr4100 microplate reader. (i) the first question concerns the analysis of 5-parameter curve marquardt: for (adjustments) analyzes of 5 marquardt parameters a concentration of exactly zero can be displayed for samples with high od values ​​and high concentrations when the curve analysis of 5 parameters marquardt is used for non-sigmoidal standard curves without upper plateau. (ii) the second question concerns the user management system (ums): users who have been blocked by the administrator can still log in.
  • Acción
    Field Action Code Bio-Rad_AC-001/2018 triggered under the responsibility of Bio-Rad Laboratorios Brasil Ltda. Sending of Communiqué.