Alerta De Seguridad para Trade name: Immuno-LATEX ASLO 2.5ML. Technical Name: ESTREPTOLISIN O - ASLO. ANVISA registration number: 10310030090. Class of risk: II. Model Affected: COD .: 21000-L. Affected Batch Numbers: Batch Affected: 17C065 / 17C067 / 17D151 / 17D153

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

¿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
    2352
  • Fecha
    2017-07-08
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    Action: We ask customers / distributors to check in their inventory the aforementioned lots. Please segregate material for WAMA to perform immediate replacement. Also inform all the direct customers (laboratories) who have bought that we will exchange their stocks. Batches made from this date will be accompanied with greater sampling to follow the effectiveness of the actions taken to regularize the test (AC 20170748). 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 - Date of identification of the problem by the company: 07/21/2017 - Date of notification notice to Anvisa: 07/28/2017 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
    According to customer complaints and internal analysis of the quality control, there was a high reactivity index for aslo (false positive). in the confirmatory tests with the kits returned by the customer and kits of accompaniment the origin of the complaint was observed. several comparative analyzes were carried out confirming the problem with the batches affected, according to the documentation and analysis report of the quality control of wama, sent to the clients.
  • Acción
    Field Action Code 001-B / 17 triggered under the responsibility of the company Wama Produtos Para Laboratórios Ltda. Pick up and return to the manufacturer.