Events

Alerta De Seguridad para E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affected model: n / a Serial numbers affected: - Reference number 537300: 100483220 , 1004437930,1004329220,1004190730,1004171220,1003969990,1003767080,1003725600,1003610660,1003532330,1003514810, 1003409250,1003297790,1002849110,1002816570,1002780680,1002594030,1002517610,1002438560,1002336190,1002154530,1001742150,1001496200,1001417080 1001260560.1001158900, 1000941970,1000893880,1000756330 and 1000714690. - Reference 537308: 10044750,1002523000,1002703940,1002795210,1002889130,1002989530,1003456440,1003456440 1003616140,1003767090,1004177660,1004596710,1004752310 and 1002343060

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; 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
    2007
  • Fecha
    2016-08-10
  • 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
    According to company information: 1- Share the information with all laboratory staff. 2- Continue the use of the E-test Colistin CO256 for diagnosis of strains of Enterobacteriaceae, only if done in conjunction with Mueller Hinton E of bioMérieux. 3- If the client does not use Mueller Hinton E from bioMérieux, or if other strains other than Enterobacteriaceae are tested, we recommend the restricted use of the E Colistin CO256 E-test for epidemiological surveys. As this is a test only for use by healthcare professionals, it does not fit recommendations to patients. ### Update of the field action: UPDATED ON 10/25/2017, the company presented the report of completion of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    Based on scientific publications (including eucat) on gradient tests and colistin diffusion discs, including e-test (ref .: 537300 and 37308), biomérieux was alerted to a potential underestimation of mic values ​​for enterobacteriaceae and acinetobacter microorganisms . biomérieux began an investigation to confirm the performance of the product and determine the root cause of the problem.
  • Acción
    Field Action No. FSCA 3061, triggered under the responsibility of the company bioMérieux SA Risk classification: II Classification of the field action: Sending of guidance letter to the customers who acquired the lots distributed in Brazil. Sample letter attached to this form.

Device

E-test colistin (30 and 100 strips) ANVISA registration number: 10158120623 Hazard class: II Affe...

Manufacturer

bioMérieux Brasil Indústria e Comércio de Produtos Laboratoriais Ltda.; bioMérieux S.A.