Events

Alerta De Seguridad para Product Name: LYRA II AGLUTINATION REACTION READER - Log: 80004040165 - Model: 854002 - Affected batches / series: 407; 422; 423; 424; 434; 451; 453; 454; 461; 462; 465; 468; 471; LY0H000201; LY0H000203; LY0K000303; LY0K000305; LY0K000306; LY1B000401; LY1B000402; LY1B000403; LY1B000409; LY2C003904; LY2C004004; LY3F007301; LY3F007302; LY3F007303; LY3F007304; LY3F007308; LY3I007507; LYB000407; LYB000410 (SEE 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 DIAMED LATINO AMÉRICA S.A..

¿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
    1643
  • Fecha
    2015-07-27
  • 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
    Immediate Protective Action - Customer Guidelines: • Use only an empty microplate for balancing purposes. For example: when only one microplate is read; • Check the color of the results presented by the Maestro software during validation; • Do not validate results if well images appear in black and white.
  • Causa
    It has been shown that in exceptional circumstances, the lyra ii agglutination reaction reader software (ms registry 80004040165) may incorrectly attribute the result of a microplate previously read to the microplate being processed. when this occurs, incorrect results are displayed in black and white instead of colored. according to a company risk assessment, "the likelihood of reporting an erroneous outcome is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously. to date, no incident with patient has been reported.".
  • Acción
    Company is informing its customers about the problem so that they take the appropriate preventive measures until a definitive solution is released through a new software version. It is reported that "the probability of reporting an erroneous result is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously." To date, no incident with patient has been reported. "; Action: Update, correction or supplementation of the instructions for use Code: AC 2015/02 SEE ATTACHMENTS: (i). Important Notice of Field (AC) - AC Number: 2015/02; (ii) .CORRECTIVE ACTION NOTIFICATION ACKNOWLEDGMENT (AC 2015/02)

Device

Product Name: LYRA II AGLUTINATION REACTION READER - Log: 80004040165 - Model: 854002 - Affected ...

Manufacturer

DIAMED LATINO AMÉRICA S.A.