Events

Alerta De Seguridad para FAMILY ESTER, Brand: Biomerieux, Model: piperacillin / tazobactam - 30 and 100 strips (in blister pack); piperacillin / tazobactam - 30 and 100 strips (in foam cartridge). piperacillin / tazobactam - 30 individual strips (in single pack). Record: 10158120623, Reference 412431: Lots: 1004331500; 1004271120; 1003415090; 1003276060; 1003069230; 1002488490; 1001936360; Reference 521418 Lots: 1004276460; 1004180840; 1003980200; 1003416920; 1002995820; 1002482640; 1002375410; 1002276210; 1002092270

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomerieux Brasil S.A.; 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
    1768
  • Fecha
    2015-12-07
  • 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 the company the risk to the patient, with the change in performance with Etest Piperacillin / Tazobactam, is the potential error in releasing incorrect results for this antibiotic, mainly in relation to false sensitivity. This risk can lead to medical intervention for the patient, because this incorrect result may negatively influence the choice of appropriate therapy.
  • Causa
    Reporting of low mic value. increased incorrect results, false sensitivity results, when compared with reference test (broth microdilution). an investigation has begun to confirm the performance of the product and to determine the root cause.
  • Acción
    Collection, destruction of the product and blocking of marketing. The company will forward Letter to all customers who have purchased the product and instruct them to discontinue use and remove affected lots. The company will replace the kits. It is important to pass the alert to all the professionals of the laboratories that work with this product. Action code: 2709.

Device

FAMILY ESTER, Brand: Biomerieux, Model: piperacillin / tazobactam - 30 and 100 strips (in blister...

Manufacturer

Biomerieux Brasil S.A.; Biomerieux S.A.