Device Recall Sysmex

  • Modelo / Serial
    Lot number A5053, Expiration date 12/21/2016 Lot number A5054, Expiration date 12/21/2016 Lot number A5041, Expiration date 9/2/2016 Lot number A5042, Expiration date 9/2/2016 Lot number A5044, Expiration date 10/2/2016 Lot number A5046, Expiration date 11/9/2016 Lot number A5047, Expiration date 11/17/2016 Lot number A5048, Expiration date 11/17/2016 Lot number A5049, Expiration date 11/26/2016 Lot number A5050, Expiration date 11/26/2016 Lot number A5055, Expiration date 12/24/2016
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (Nationwide, Washington DC) Canada; Cuba; Chile; and Dominican Republic.
  • Descripción del producto
    Fluorocell PLT reagent, Catalog #CD994563 || Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

8 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484;   2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.
  • Descripción del producto
    The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
  • Modelo / Serial
    **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001  29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867  **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada
  • Descripción del producto
    Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
  • Manufacturer
  • Modelo / Serial
    Catalog number SIM-220A, lot numbers C9010, C9011, C9013, C9014, C9015, C9016 and C9017
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA (nationwide) and the countries of Brazil, Canada and Honduras.
  • Descripción del producto
    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. || The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
  • Manufacturer
  • Modelo / Serial
    catalog #983-1341-1, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including Puerto Rico.
  • Descripción del producto
    Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 || The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
  • Manufacturer
  • Modelo / Serial
    catalog #063-7591-7, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including Puerto Rico.
  • Descripción del producto
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 || The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results.
  • Manufacturer
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