Alerta De Seguridad para Trade name: OneHbA1c IS. Technical Name: Glycosylated hemoglobin. ANVISA registration number: 10350840200. Class of risk: II. Affected Model: 100 cartridges (R1: 350uL / R2: 75uL / R3: 80uL) + 10 Cleaner Tubes (1800uL) + Paramcard Card. Lots of numbers affected: 60121004; 6,011,9264; 60119656; 60121001

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biosys Ltda.; DiaSys Diagnostic Systems GmbH.

¿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
    Check your inventory and identify products at risk by checking the lot numbers described. If you locate an affected product stop using them immediately by identifying the product to avoid inadvertent use. The balance in stock, if any, must be returned to Biosys care or properly discarded, with proof of disposal. Biosys will reset the number of affected kits. 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: 09/03/2018 - Date of notification notice to Anvisa: 04/16/2018 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
    According to the manufacturer of the product, internal investigations related to information received from the customer showed that, due to specific temperature effects, the batches mentioned in this alert can lead to the deviation of results in patients due to instabilities of the reagent. the company reported that it had not received any complaints related to this interference in national territory.
  • Acción
    Field Action Code 4683 triggered under the responsibility of the company Biosys Ltda. Product pickup.