Device Recall VITROS ECiQ Immunodiagnostic System

  • Modelo / Serial
    Serial Numbers between 30003000 and 30005177; All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ B-hCG II (human chorionic gonadotropin) Reagent Packs is processed are affected by this correction. --- Note: All systems that are installed worldwide have Software Version 3.8 or lower installed on them, but B-hCG is not processed on all systems worldwide.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
  • Descripción del producto
    VITROS¿ ECiQ Immunodiagnostic System, Catalog No. 1922814 --- COMMON/USUAL NAME: VITROS¿ ECiQ System --- Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester, NY 14626 --- All systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. || Product Usage: || For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA