Alerta De Seguridad para Trade name: Nuclisens Lysis Buffer (Lise Nuclisens Buffer). Technical name: Buffers, Electrolytic Solutions, Diluents and other Solutions for Laboratory Analysis. ANVISA registration number: 10158120527. Risk class: I. Model affected: N / A. Serial numbers affected: Lot: 17022802

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por bioMperieux Brasil Ind e Com de Prod Laboratoriais Ltda..; BIOMERIEUX 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
    Required actions: We request the following actions at the moment: - Send the "Product Safety Correction Notice" to the NucliSENS® Lysis Buffer product (Reference: 200292) to users who received impacted lot 17022802, in order to receive the information associated with this Field Action - Destroy any remaining stock of NucliSENS® Lysis Buffer (Reference: 200292) lot 17022802 which may still exist in the company stock. you may have with respect to the previously reported results, with your Laboratory Medical Officer, to determine the appropriate course of action.Contact bioMérieux customer service if you notice the problem.If you wish to notify technical grievances and events Adverse events (AE) and technical complaints (QT) for products subject to Health Surveillance should be done 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: 07/13/2017 - Date of notification notice to Anvisa: 09/28/2017 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
    Following a customer complaint regarding colored eluates for whole blood extractions when using nuclisens® lysis buffer, an r & d investigation was initiated .; research has shown that the eluate becomes colored because of the presence of the heme group. therefore, impacted matrices are whole blood samples, including dry blood stains and faeces, especially when the samples are of low quality (hemolysate, frozen / thawed several times, fraction removed from plasma). the root cause of the staining was confirmed to be bound to a non-conforming ph value for lot 17022802. a ph value of 6.9 was observed at 21.0øc instead of 7.0-7 , 2, according to the product specification. the investigation confirmed that no other batch available today in the field was affected by the same non-compliance of the ph.
  • Acción
    Field Action Code FSCA 3630 triggered under the responsibility of the company bioMperieux Brazil Ind and Com de Prod Laboratoriais Ltda.