Device Recall SUNRISE

  • Modelo / Serial
    Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5219GYJ, Instrument Serial #1606001277 and PC Serial #CND5219GZW, Instrument Serial #1606001263.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
  • Descripción del producto
    SUNRISE instrument. || The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    1)-Model Number : Hoy - Advance - E with Serial numbers: 0601L0433 through 0601L0441, 0603L0294 through 0603L0336, 0603L0493 through 0603L0501, 0603L1011 through 0603L1021, 0603L1139 through 0603L1187, 0603L1285 through 0603L1294, 0604L0394 through 0604L0411, 0604L0885 through 0604L0941, 0604L1002 through 0604L1012, 0606L0365 through 0606L0431, 0606L0789 through 0606L0818, 0606L1006 through 0606L1030, and 0607L0001 through 0607L0090--2)Model Number: Hoy - Advance - H with Serial numbers: 0601L0442 through 0601L0459, 0603L0286 through 0603L0293, 0603L1022 through 0603L1041, 0603L1295 through 0603L1330, 0603L1519 through 0603L1572, 0605L0742 through 0605L0753, 0606L0049 through 0606L0142, 0606L0819 through 0606L0848, and 0606L1031 through 0606L1144
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and country of Canada.
  • Descripción del producto
    Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.
  • Manufacturer