Events

Alerta De Seguridad para CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10350840138 Hazard Class: II Affected Model: R1: 5 x 20 mL / R2: 1 x 25 mL Serial Numbers Affected: 60109928

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por BIOSYS LTDA; DiaSys Diagnostic Systems GmbH.

¿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
    2130
  • Fecha
    2016-12-19
  • 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
    Customers / users who have purchased the batch related to this notification are directed to segregate all units of the product as nonconforming product and returned to our care, for later replacement by another suitable batch. It is further recommended that the results eventually measured with the quoted batch be checked using another batch number. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action, with sending evidence of the collection and destruction of the affected products.
  • Causa
    Biosys ltda., the record holder of the referenced product, received a communication from the international manufacturer of the same, diasys diagnostic systems gmbh, stating that of the product colinesterase fs lot 60109928 had to be withdrawn from the market due to a failure in the packaging process of the product. reagent r2 and the units already marketed should be collected. due to failure of the r2 container both patient and control samples will show false low results or even an error report in the results to and process the enasio in automatic machines. biosys informs that it has not received a customer complaint related to the product in question.
  • Acción
    Field Action Code 4130 triggered under the responsibility of the company BIOSYS LTDA. Company will collect for further destruction.

Device

CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10...

Manufacturer

BIOSYS LTDA; DiaSys Diagnostic Systems GmbH
  • Source
    ANVSANVISA