Alerta De Seguridad para MicroScan Pos Combo Panel Type 41, culture medium, Beckman Coulter brand, registration 10033120934, hazard class II, lot: 2016-05-04.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Beckman Coulter do Brasil Comércio e Importação de Produtos for Laboratórios Ltda.; Beckman Coulter 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
    1793
  • Fecha
    2015-01-08
  • País del evento
  • Fuente del evento
    ANVISA
  • 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
    The VP test is used for the identification of gram positive cocci gram-negative catalase, PYR negative and bile esculin negative. This specific test is used for differentiation of the Streptococcus species from the viridans Group, being of epidemiological importance, since the whole group has the same pathogenicity. /// If the panel is used for isolated clinical testing, the impact is potential for any of the following combinations: high probability of misidentification, poor likelihood of identification or very rare biotypes due to incorrect VP results.
  • Causa
    The results would be falsely negative for the voges-proskauer (pv) test (light pink / brown / colorless) with the quality control (qc) of the organism staphlococcus aureus atcc 29213. the expected result is positive for this test.
  • Acción
    Collection and destruction of culture media. Action code: FA-26321. The company directs to stop the use of the medium and discard any remaining stock from the lot quoted. Fill out and send to the record holder a form requesting the replacement of the product. Keep inventory of other batch numbers in this panel because you are not affected by this problem. Discuss the content of the action with the laboratory director regarding the need to analyze the results of previous tests, propose follow-up of the patient or repeat the test using another panel batch if the isolates are still available.