Events

Alerta De Seguridad para Trade name: Family of KLA's for HLA Typing Test Class I Locus A, B and C and Class II Locus DR and DQ Technical Name: HLA Typing Kit for Class I and II-Labtype ANVISA Registration Number: 80298490005 Hazard Class : III Model affected: RSSO2Q, RSO2QT, RSSOH2B1, RSSo2B1, RSO2B1T, RSSO1S4, RSO1S4T and RSSOMICA Serial numbers affected:

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por 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
    2063
  • Fecha
    2016-12-23
  • 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
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    The reading catalog provided by the manufacturer contained incorrect or missing information. labtype kits typify hla genes. after the technical hla typing procedure with labtype kits in the laboratory, the test is read on a flow cytometer equipment. raw data is generated that needs to be analyzed by the specific software (hla fusion or by spreadsheet for manual analysis). in order to arrive at the typing result, the software requires analysis catalogs, which are data that feed the database provided by the kit manufacturer, which contains information concerning the hla gene alleles. the hla nomenclature is quite specific and undergoes constant updates, as new alleles are constantly discovered. the catalogs are specific to each locus genius because the typing is locus specific, and are also directly related to the batch of each labtype kit. in this case, the documentation assists the user in the interpretation of the result was with incorrect or missing information.
  • Acción
    Field Action Code OC1451 triggered under the responsibility of the company BIOMETRIX DIAGNOSTICA LTDA. Company will make correction in the field.

Device

Trade name: Family of KLA's for HLA Typing Test Class I Locus A, B and C and Class II Locus DR an...

Manufacturer

One Lambda, Inc.