Events

Alerta De Seguridad para VITROS NT-PRO BNP REAGENT KIT Technical Name: HUMAN BRAIN NATURAL URBRID PEPTIDE (BNP) ANVISA Registration Number: 80145900933 Hazard Class: II Affected Model: Kit consisting of: 100 coated wells; 8.2 ml of conjugated reagent; 8.2 ml of biotinylated antibody reagent. Affected batch / serial numbers: SKU 6802156, lot 1570, 1580

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.

¿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
    2263
  • Fecha
    2017-04-11
  • 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
    • If you are currently able to perform a successful calibration, implement the revisions on your VITROS System at your next scheduled calibration: o For VITROS® ECi / ECiQ Systems: Scan the Magnetic Batch Card for Batch 1580 or 1590. Discard / Original Magnetic Batch Card (green), supplied with the product. o For VITROS 3600, 5600 Systems: Install ADD DRV 5923 and later. Install the ADD using the "Full Load" (All Assay Data) option. After loading the ADD for the first time, the VITROS Reagent Kits for NT-proBNP will lose the calibration and must be recalibrated. After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory. NOTE: For e-Connected systems, download is available as of March 13, 2017. • If it is not possible to calibrate Batches 1580 or 1590, upon availability, use the new Magnetic Batch Card or ADD DRV 5923 for calibration. • If you have this problem and you no longer wish to use this product, Ortho will credit your account for the discarded product, or you will reimburse it for another product you have indicated. Resend the Receipt Confirmation form to indicate the amount that requires credit. • Place this notification next to each system that processes the VITROS Reagent Kits for NT-proBNP.
  • Causa
    Ortho clinical diagnostics (ortho) informs about the potential inability to obtain a successful calibration using the batches listed below the vitros reagent kits for nt-probnp. it was confirmed that affected batches of vitros reagent kits for nt-probnp showed the potential for a higher frequency of calibration failures, with an unexpected increase in the level 1 calibrator signal, potentially causing a failure of the calibration parameters. our preliminary tests indicate that the calibration failure is related to a component of the vitros reagent kit for nt-probnp and is not associated with the vitros calibrators for nt-probnp. ortho is working to determine the root cause. until the cause is identified, the company will monitor all current and future batches to monitor performance and issue additional notifications and corrective / preventive actions, as appropriate.
  • Acción
    Field Action Code TC2017-048 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make field alert.

Device

VITROS NT-PRO BNP REAGENT KIT Technical Name: HUMAN BRAIN NATURAL URBRID PEPTIDE (BNP) ANVISA Reg...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics