Events

Alerta De Seguridad para Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​/// Risk Class: II - products of medium risk to the individual and / or low risk to public health, subject to registration /// Lots: 69781101 /; 69781401; 69780301 (SCHEDULE OF DISTRIBUTION IN ANNEX)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical.

¿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
    1549
  • Fecha
    2015-04-10
  • 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
    Actions to be taken by the customer / user, according to the company: • Customers must stop using the affected product (affected batches), eliminating it locally and switching to subsequent batches of HCYS that are not affected: Batch Affected: 69780301 / 69781101/69781401 - Expiry date30 / 04/2015 - Using Subsequent Batches: 607116101/60716801/60717101 - Validity 1/31/2016
  • Causa
    The company reported that "customers complained of a 20% decrease in control levels when using non-roche controls (eg, thermofisher liqimmune) with the reagent homocysteine ​​from lot 697811 on cobas c 501 equipment. lot 604303, controls were within range. comparison of patient samples with reagent lot 697811 versus lot 604303 showed a deviation of up to 54%. plasma samples were used in edta. this negative deviation could result, in the worst case, in low homocysteine ​​results. however, it is unlikely that inaccurately low homocysteine ​​results could have caused an immediate adverse event, since homocysteine ​​has been shown to be an indicator of long-term cardiovascular risk (late cardiac events) rather than short-term events. ".
  • Acción
    Company communicated its customers by letter (LETTER IN ANNEX) Type of action: Notice to Customers and Distributors not to use affected lots (LETTER IN ANNEX) /// Code: SBN_RPD_2015_006

Device

Homocysteine ​​Enzymatic Assay /// Registration 10287411008 /// Technical Name: Homocysteine ​​//...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH; Unomedical