Alerta De Seguridad para Products Affected: VITROS ANALYZING SYSTEM / CHEMICAL SYSTEM VITROS 4600 / CHEMICAL SYSTEM VITROS 5600 / CHEMICAL SYSTEM VITROS 5.1 FUSION. Anvisa Registers: 10132590681. VITROS® 250 System (Reg ANVISA 10132590681). VITROS® 350 System (Reg ANVISA 10132590681). VITROS® 4600 Chemical System (Reg ANVISA 80145901335). VITROS® 5600 Integrated System (Reg ANVISA 80145901205). VITROS® 5.1 Fusion Chemical System (Reg ANVISA 80145900827). Risk class: II. Affected Series / Lots: Includes all VITROS® 250, 350, 4600, 5600 and 5.1FS Diagnostic Systems.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; ORTHO CLINICAL DIAGNOSTICS, 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
    1805
  • Fecha
    2016-01-25
  • 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
    1
  • Causa
    Condition codes u90-382 or 6lu are associated with lavage errors that may occur when using vitros® chemicals for immunoenzymatic assays (vitros® crbm, crp, dgxn and phyt slides). if a u90-382 or 6lu condition code associated with a wash error occurs, the condition code text located on the vitros® system and other user documents indicates to dilute the sample. however, dilution may not be the appropriate action in all cases.
  • Acción
    a) Field action classification: Field correction with software update b) Field action code: 15000183 c) Recommendations to users and patients: For results indicated with a Wash Error code - WE: Follow the recommended actions described in your user documentation. • If a single sample has been diluted and reprocessed: o If the calculated result in the diluted sample exceeds the measuring range, the result will be acceptable. o If the WE code in the same sample occurs again or the calculated result does not exceed the measurement range, use an alternative method to perform the test. • Place this notification on your VITROS® System or along with your user documentation.