Device Recall VITROS ECi Immunodiagnostic System

  • Model / Serial
    Serial Numbers between 30000127 and 30002743. All VITROS¿ ECi/ECiQ systems that have Software Version 3.8 or below installed and on which the VITROS¿ Total 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 Total B-hCG is not processed on all systems worldwide.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    VITROS¿ ECi Immunodiagnostic System, Catalog No. 8633893 --- COMMON/USUAL NAME: VITROS¿ ECi 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

Manufacturer

  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA