Alerta De Seguridad para Trade name: ID-Card Diaclon Abo / D + Proof Reversal. Technical Name: Immunohematology - ABO - Monoclonal Origin. ANVISA registration number: 80004040061. Risk class: IV. Affected model: 00 000 000 0012 35. Lot numbers / series affected: Lot: 50092.95.19 - ID-Card numbering sequence from 23,000 to 31,000

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Diamed Latino América S.A..

¿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
    1. We request that the customer verify that the ID-Card numbering sequence present on the DiaClon ABO / D + Reverse Proof Lot 50092.95.19 product's internal label is between 23,000 and 31,000 2. The numbering sequence of the ID-Card is 23,000 to 31,000, immediately stop using the DiaClon ABO / D + Reverse Proof lot 50092.95.19 card, identify and segregate the box (s) for subsequent return to Bio-Rad 3. Inform the quantity of boxes in your stock that have ID-Cards with the numbering sequence between 23,000 and 31,000, so that we can carry out product replacement. 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: 11/04/2018 - Date of notification notice to Anvisa: 04/18/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. 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
    It was verified by the bio-rad quality control that the results of the tests using the diaclon abo / d + proof reversal id card, lot 50092.95.19, may present a weak non-specific reaction in the last microtube referring to the reverse test hematin "b". we note that this unexpected reactivity is restricted to only a few units of this lot, sequence numbering from id-card from 23,000 to 31,000.
  • Acción
    Field Action Code AC 2018/02 triggered under the responsibility of the company Diamed Latino América SA Product pickup.