Device Recall Perkin Elmer

  • Modelo / Serial
    Serial Numbers: DG01130042 DG01130083 DG01130122 DG02130179 DG03130196 DG03130242 DG04130300 DG04130318 DG05129208 DG05129239 DG05129251 DG05130343 DG06129284 DG06129320 DG07129407 DG07129433 DG08118247 DG08129522 DG08129575 DG09129612 DG09129619 DG09129643 DG10129707 DG10129728 DG10129768 DG11129836 DG11129838 DG12120004 DG12120038 SGWZ03150235 SGWZ04140103 SGWZ07140107 SGWZ07140108 SGWZ14140125 SGWZ16140131 SGWZ16140134 SGWZ20140150 SGWZ21140152 SGWZ27130022 SGWZ28140168 SGWZ29130026 SGWZ32130030 SGWZ33140183 SGWZ35140188 SGWZ36130039 SGWZ37130044 SGWZ39130048 SGWZ42130051 SGWZ43130053 SGWZ43130056 SGWZ44130057 SGWZ45130062 SGWZ47130076
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) and the countries of ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CHINA COSTA RICA CROATIA CZECH REPUBLIC DENMARK ETHIOPIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA KUWAIT LUXEMBOURG MEXICO MYANMAR NETHERLANDS NORWAY PHILIPPINES POLAND REUNION SAUDIA ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UK.
  • Descripción del producto
    WIZARD2 2-detector, 550 samples || Product Code: 2470-0020 || The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

23 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Serial numbers from 20210012 to 20210021
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
  • Descripción del producto
    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
  • Manufacturer
  • Modelo / Serial
    Serial Numbers: 20210001 through 20210078
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,
  • Descripción del producto
    Perkin Elmer Genetic Screening Processor (GSP) || Product Code: 2021-0010 || Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 618201, 619200, 618263
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    NEONATAL TOTAL GALACTOSE KIT || Product Numbers: 3029-0010, 3029-001B. || This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
  • Manufacturer
  • Modelo / Serial
    Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175
  • Clasificación del producto
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Microplate, truncated V-bottomed lots included in the || above listed products || Product Number: 1380 5465. || DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
  • Manufacturer
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