Events

Alerta De Seguridad para Labscreen Multi HLA Class I and III and HNA Technical Name: Labscreen Multi HLA Class I and III and HNA Registration Number ANVISA: 80298490004 Hazard Class: III Affected Model: LSMUTR Affected Series Numbers: Lot: 007 Batch: 0000091458 , 0000099706 and 0000145845

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biometrix Diagnóstica Ltda.; One Lambda, Inc..

¿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
    2289
  • Fecha
    2017-05-16
  • 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: User guidance to use the Instructions for Use LABScreen Revision 9 (LMMUTRPI Ver 9), which can be consulted on the One Lambda website, and discontinue the document LABScreen Multi Revision 8 (LMMUTRPI Ver 8). If the product was analyzed using LABScan 3D (Luminex FM3D), reanalyze the results using LABScan 100 (Luminex 100/200) to ensure the accuracy of the results.
  • Causa
    Field action code 2018 triggered under the responsibility of the company biometrix diagnostica ltda. company will update, amend or supplement the instructions for use. the manufacturer has notified the distributor that the instruction for use of the labscreen multi hla class i and ii and hna (lsmutr) product containing divergent required instrument information has been released. the code usage instruction lmmutrpi ver 8, released on 04/20/2016 contained as required instrument the labscan 3d equipment, however the required instrument is the labscan 100. the product works as indicated, this error is for documentation only.
  • Acción
    Field Action Code 2018 triggered under the responsibility of the company Biometrix Diagnostica Ltda. Company will update, correct or supplement the instructions for use.

Device

Labscreen Multi HLA Class I and III and HNA Technical Name: Labscreen Multi HLA Class I and III a...

Manufacturer

Biometrix Diagnóstica Ltda.; One Lambda, Inc.
  • Source
    ANVSANVISA