Device Recall VIDAS

  • Modelo / Serial
    Description, Reference No. (UDI No.): VIDAS ANALYSER 110/220V, 93296 (03573026133573); VIDAS ANALYSER 220V, 93297 (03573026133580); VIDAS ANALYSEUR, 99011 (03573026109257); VIDAS ANALYSER EU, 99444 (03573026114060); VIDAS ANALYSER US, 99445 (03573026114084); VIDAS ANALYSER, 99735 (03573026140427); VIDAS ANALYSER US, W2205 (03573026029678); VIDAS ANALYSER, 410417 (03573026351663); Quality Control VIDAS¿ (QCV), 30706 (03573026121631); VIDAS ANALYSER EU, W3205 (03573026030292); VIDAS INDUSTRY US, 421002 (03573026553319)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY. International distribution to Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Cape Verde, Chad, Chile, China / Hong Kong, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Mauretania, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Tanzania, Thailand, Togo, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zimbabwe.
  • Descripción del producto
    BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) || Product Usage: || the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    REF: #412590, Lot: Software version 1.1.4
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    U.S.
  • Descripción del producto
    VIDAS 3 software v. 1.1.4
  • Manufacturer
  • Modelo / Serial
    Lots 1005081700, 1005172850 & 1005359170
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
  • Descripción del producto
    VIDAS Estradiol II, Ref 30431-01, 60 tests || The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
  • Manufacturer
  • Modelo / Serial
    Lots 1004878310 & 1005001080
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine
  • Descripción del producto
    VIDAS Testosterone, Ref 30418
  • Manufacturer
  • Modelo / Serial
    Catalog #30 204, Lot #782887501
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.
  • Descripción del producto
    VIDAS¿ CMV IgG Assay
  • Manufacturer
  • Modelo / Serial
    Catalog number: 30101-01, Lot number 868400501.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution- including CA, DC, FL, IL, IL, IN, MD, MI, MN, MO, MT, NC, NE, NJ, NY, PA, UT, VA and WI.
  • Descripción del producto
    VIDAS Chlamydia test kits || VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using the ELFA technique (Enzyme Linked Fluorescent Assay.
  • Manufacturer