Device Recall Simplexa Flu A/B &38; RSV Direct

  • Modelo / Serial
    Model Number: MOL2650. All Lot Numbers. The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. || 510(k) K120413  Simplexa" Flu A/B & RSV Direct. || The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source