Device Recall enGen(TM) Laboratory Automation System

  • Modelo / Serial
    US Serial Numbers: JFBX395J, GBX395J, J953252, JJXBQW4J, J3RHC23J, J86PWC5J, J5LQ6Q2J, JFCM073J, J54FC01J, J5J4B45J, J7KSC15J, J4HX7S4J, JGWXQ52J, J953221, JG7BFB5J, JHPKG25J, JCXL941J, J736BM4J, JFXCBG3J; -- Foreign Serial Numbers: J89133 (VAS), JHWJZY4J, J3J4B45J, J953244, JCT20Q3J, J16XQH4J, GWJVY4J, DWX052J,  J271264, J271368, J271371, J271269, J85206, J953216, DP2LF62, J7023874, J7023847, J7025017, J7024893, J7023645, J7023435, J57663, J800103, S/N 89VQ762 (VAS), J75863, J75691, J30372, J3055503, J3055496.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed in the states of MD, NY, ID, NC, CO, OH, PA, TN, MS, MO, CA, DE, FL, GA, AZ, NJ, and WV and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Saudi Arabia, Spain, Sweden, Thailand, and United Kingdom.
  • Descripción del producto
    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Empresa matriz del fabricante (2017)
  • Source