Events

Alerta De Seguridad para AUTO D-DIMERO AMAX CRS126-B - Registered in Anvisa under the number 10071770465 - LOTS: T082003 / T084001 / T119006.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medlab Produtos Médico Hospitalares 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
    981
  • Fecha
    2009-09-17
  • 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
    Observe that the instructions for use of the product indicate that the results should be used with other clinical information and laboratory diagnosis, for the formation of the diagnosis and for the follow-up of the patient. Although it is estimated that the clinical risk is low, it is recommended that the end-user check the calibration curves and make the appropriate determination based on the use of the test and re-test any high sample whose result may be underestimated. Anvisa is following this field action.
  • Causa
    The company reports that after internal investigation, when the calibration curve was generated with the reference batches of the auto d-dimero amax crs126-b product, it was observed that there is a possibility that the two highest points of the curve are not distinguished from one of the and the very high values ​​of dimero d, although they remain high, can be underestimated. a research test showed that in some cases samples greater than 30,000 ng / ml fell within the calibration curve without dilution. there is no indication that this fact could cause an increase in the normal value of d-dimer.
  • Acción
    The actions recommended to users of the product are as follows: (1) Immediately stop using the product; (2) Locate the product with the affected batches in your inventory and segregate them. (2) Return them to the dealer for disposal. (3) Forward the Form for Verification and Traceability Response to Medlab Produtos Médico-Hospitalares Ltda. - A / C Luiz Alberto Marin - Phone: (011) 2131-5137 or e-mail luiz.marn@medlabgroup.com.br.

Device

AUTO D-DIMERO AMAX CRS126-B - Registered in Anvisa under the number 10071770465 - LOTS: T082003 /...

Manufacturer

Medlab Produtos Médico Hospitalares Ltda.
  • Source
    ANVSANVISA