Events

Alerta De Seguridad para Nuclisens easyMag Magnetic Silica Technical Name: Nuclisens easyMag Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Serial Numbers Affected: Z017DA1MS (Expired on 04/28/2017)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por bioMérieux 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
    2071
  • Fecha
    2016-07-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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-Distribute information on the problem with Nuclisens easyMam MangeticSilica to all technical personnel in the laboratory, keep a copy in the technical files, share the information with everyone who can use the product, including others to whom you are interested. distributing the lot concerned. 2- Reduce the sample to be tested to a volume of at most 200uL, until the occurrence of the product is not identified until the Silica is changed. 3- Use an internal extraction control that mimics the objective (same nature / structure) or external controls as directed at the product line and the GLP, to detect any performance problems in the extraction. 4- Discuss any technical questions you may have, prior to issuing the results of your lab, to your lab's Medical Director to determine the appropriate course of action. 5- Contact the bioMérieux Brasil customer service team if you notice the problem. 6 - Cmplete and return the Knowledge form, so that we can register the receipt of the letter and the guidelines by your institution. #### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client.
  • Causa
    Some customer complaints were recorded when in-house methodologies were applied for pcr and rt-pcr assays. customers complained about performance problems in amplification when they used different batches of magnetic silica (ref. 280133) as well as the nuclisens easymag extraction platform. this is due to the variability in the quality of magnetic silica. the difference above 1 log in quantification was observed for some clients when using their own in-house validation methodology for dna assays. the difference of 1log is significant about the results. as the donwstream applications are qualitative and / or quantitative methods, the decrease in the performance of this application can lead to: 1- risk of false negative for qualitative tests; 2- invalid resets, when the control of the internal application is not within the specifications; 3 subquantified results for quantitative tests. all customers who complained identified the problem with the help of internal and external extraction controls either directly on the kit's objective or during check-in control when switching from one batch of silica to another. the investigation (pr 978900) identified impact in: 1- extraction volumes greater than 400ul; 2- double-stranded nucleic acid targeting assays; 3- the size of the genome to be detected 4 aggravating factor: applications for small double-stranded nucleic acids (<40kbp) and medium genomes (<1200 kbp), eg. dna viruses, are more impacted than superior human genomes or bacterial applications (> 1200kbp).
  • Acción
    Field Action Code FSCA 3037 triggered under the responsibility of bioMérieux. Company will make correction in the field.

Device

Nuclisens easyMag Magnetic Silica Technical Name: Nuclisens easyMag Magnetic Silica ANVISA Regist...

Manufacturer

bioMérieux S.A.