Events

Alerta De Seguridad para Product: Gold ELISA Chagas - Registration: 10162410454 - Technical Name: TRYPANOSOMA CRUZI - Risk Class: III (Products presenting high risk to user, patient and / or public health) - Affected lots: CHA127A; CHA 128A (Distribution map 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 REM Indústria e Comércio Ltda.

¿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
    1581
  • Fecha
    2015-05-25
  • 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, "at the end of the test, the reader (equipment used in the IVD trials) releases results values ​​that must meet the acceptance criteria indicated in the Instructions for Use. The results are analyzed by qualified persons. is foreseen in the Risk Management Report of the Gold ELISA Chagas kit, considered as a serious risk since failure to meet these criteria invalidates the reaction and makes it impossible to release results. "
  • Causa
    The company received a complaint about the performance of the positive control part of the gold elisa chagas kit, lot cha127a. it carried out investigation and concluded that this reagent presents problems with the stability being able to be outside the required minimum specifications and not to reach the result of expected optical density for the release of the test. in the traceability analysis of the production process, it was identified that the positive control pertaining to the kit cha128a lot has common components with that used in lot cha127a and, as a precaution, included it in the field action. according to the company, the investigation of the occurrence provided subsidies so that they could make sure that the problem is restricted to the positive control.
  • Acción
    Company is performing the recall (for destruction of affected lots) and directing its customers to discontinue use of lots CHA127A and CHA128A. (SEE ANNEXES) - Code: NP 80/15

Device

Product: Gold ELISA Chagas - Registration: 10162410454 - Technical Name: TRYPANOSOMA CRUZI - Risk...

Manufacturer

REM Indústria e Comércio Ltda