Events

Alerta De Seguridad para Technical Name: TECHNO - ANVISA registration number: 80004040145. Risk class: II - Affected model: 009895 - Affected lots: 212; 318; 375; 377; 490; 492; 493; 497; 507; 541; 545; 1017; 1018; 1026; 1049; 1050; 1064; 1065; 1066; 1080; 1084; D0104; D0197 (see 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 DIAMED LATINO AMÉRICA S.A.; DIAMED 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
    1770
  • Fecha
    2015-12-15
  • 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 who do not use Techno for Lu (a) E Lu (b) antigens (Lutheran Antigens) are not subject to the risk of reading incorrect results.
  • Causa
    Adverse reactions weaker than the expected may be observed for antigens lu (a) e lu (b) (antigens lutheran) when tested in the bio-rad techno equipment in internal batteries better than 24 samples, for what a long period of dispensation is necessary.
  • Acción
    a) Risk classification according to notification form: III (Situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences // b) Classification of the field action: UPDATE, CORRECTION OR COMPLEMENTATION OF THE INSTRUCTIONS FOR USE // c) Field action code: AC 2015/03 // d) Recommendations to users and patients: WE RECOMMEND THAT CUSTOMERS FOLLOW THE FOLLOWING INTRUTIONS WHEN THE ANTIGENS LUTHERAN WERE TESTED:. TEST NUMBER: PR45A [PRODUCT NAME: ANTIGEN: ANTI-LUNE / Lub (5123)] PRODUCT CODE: 006031 (ID CARD IDENTIFICATION ID NO: 51230) LIMITED BATTERY SAMPLE QUANTITY BY TECHNO: 24 SAMPLES / BATTERY , TESTED ONLY FOR THIS TEST CODE, (ii). TEST NUMBER: PR44H [TEST NAME: ANTIGEN: ANTI-LAMINE (5031)] PRODUCT CODE: 007351 (ID CARD IDENTIFICATION ID NO: 50310) LIMITATION OF BATTERY SAMPLES BY TECHNO: 24 SAMPLES / BATTERY - NOTE : CAN BE TESTED ON THE SAME BATTERY WITH THE PR44I TEST; (iii). LIMITATION OF SAMPLE QUANTITY BY BATTERY ON TECHNO: 24 SAMPLES / BATTERY - NOTE: This product has been tested and found to comply with the limits for a Class B digital device, : CAN BE TESTED ON THE SAME BATTERY WITH THE PR44H TEST; (iv). FOR TESTING: PR42A [TEST NAME: ANTIGENIC PROFILE: P1-Lea-Leb-Lua-Lub-ctl (5037)] PRODUCT CODE: 008510 (ID CARD ID NO: 50371) LIMITATION OF BATTERY SAMPLE QUANTITY NO TECHNO: 24 SAMPLES / BATTERY - NOTE: CAN BE TESTED ON THE SAME BATTERY WITH THE PR41A // TEST (SEE NOTICE TO CUSTOMERS AND NOTIFICATION SCREEN)

Device

Technical Name: TECHNO - ANVISA registration number: 80004040145. Risk class: II - Affected model...

Manufacturer

DIAMED LATINO AMÉRICA S.A.; DIAMED GMBH