Alerta De Seguridad para TDX / TDXFLX Dilution Buffer - ANVISA Register 10055310616 - Lots 19025Q100. 13173Q100 and (11335Q100, the only one affected in Brazil)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil Ltda - Divisão Diagnóstico.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    For questions or clarification, contact the Abbott Diagnostics Division Customer Service Center at 0800-11-9099, or your local representative. The UTVIG - Technovigilance Unit will be following the whole process (recall) until the moment of its closure.
  • Causa
    It was found that the tdx-tdxflx dilution buffer, when used with the tdx-tdxflx benzodiazepines (urine) assay, may cause changes in control values ​​and patient outcomes. preliminary results from an ongoing investigation indicated that the occurrence is associated with the vial in which the tampon was filled. the magnitude of the effect is directly proportional to the time the buffer is stored in the bottle. studies in abbott have shown that the occurrence does not affect other tdx-tdxflx assays. when using a single batch of tdx-tdxflx dilution buffer, you may observe that the test control values ​​and patient results decline in the absence of recalibration. when introducing a new batch of tdx-tdxflx dilution buffer, and values ​​are read from a stored calibration curve, increasing or decreasing changes in control values ​​and patient outcomes may be observed. the magnitude of the change observed during internal testing was 33.4 ml at 200 ng / ml of 25.7 ng / ml and 26.6 ng / ml at 1000 ng / ml. according to the labeling of the product, the tdx-tdxflx benzodiazepines test provides only initial analytical results. a more specific alternative chemical method should be used to obtain a confirmed analytical result. there were no claims, damages or medical events that could be attributed to this occurrence.
  • Acción
    Customer letter with label for each system (with Return of Receipt - AR) and Quality Policy for the Customer Service Center. Actions Needed: During the use of a single batch of buffer, recalibrate the TDx-TDxFLx Benzodiazepines assay every 14 days. Perform a new calibration on the TDx-TDxFLx Benzodiazepines test when a new TDx-TDxFLx lot number is used. Dilution Buffer. These actions are in addition to the calibration and quality control requirements of the instructions for use. Follow your laboratory procedures for notification to the health professionals you serve. If the TDx-TDxFLx Dilution Buffer (list number 9519-02) and / or TDx-TDxFLx Benzodiazepines (list number 9674) has been sent to another laboratory, provide a copy of the letter and inform all operators of the TDx-TDxFLx System about this release. For future reference, insert the notice in the TDx-TDxFLx system operation manual