Alerta De Seguridad para Trade name: Lysercell. Technical Name: Hematology Lysis Solution. ANVISA registration number: 80015490091. Hazard class: I. Model affected: Lysercell WDF 5L. Affected serial numbers: Batches: P7001, P7002 and P7003.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Sysmex do Brasil Indústria e Comércio Ltda; Sysmex do Brasil Indústria e Comércio 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
  • 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
    Customers who purchased this batch of product were contacted via email and possible telephone connection, which explained about the destruction of the lots acquired with the abovementioned problem; In addition to product reimbursement, customers have been advised that use of the product does not affect the end result. Letter of communication with the attached client recommendations. 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: 08/21/2017 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
    Sysmex do brasil became aware of a performance problem related to batches of reagent lysercell wdf (wdf-210a). the main cause was the use of a specific batch of a raw material present in the composition of lysercell-wdf, which compromised the quality of the final product. the final product increased the false positive results for suspect alarms, "abn lympho? b and / or atypical lympho", when the differential analysis was analyzed. however, the problem did not affect the numerical results released by the equipment.
  • Acción
    Field Action Code RO.0381 triggered under the responsibility of the company Sysmex do Brasil Indústria e Comércio Ltda. Disposal of the product for health if the problem is found.