Bayer Healthcare, LLC (Diagnostics Division)

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Description

7 dispositivos en la base de datos

  • Modelo / Serial
    All ADVIA 2400 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 2400 Part # 073-A010, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Modelo / Serial
    All ADVIA 1650 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1650 Part # 073-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Modelo / Serial
    All ADVIA 1200 Chemistry Systems are involved as well as all existing assay lots for Valproic Acid (VPA), Phenytoin (PHNY), Gentamicin (GENT), Digoxin (DIG), and Theophylline (THEO). ADVIA 1200 Part # 094-A001, VPA Part # B01-4784-01, PHNY Part # B01-4775-01, DIG Part # B01-4769-01, GENT Part # B01-4787-01, THEO Part # B01-4772-01.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide, including USA, Puerto Rico, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, Spain, Saudi Arabia, Sweden, Switzerland, Syria, Taiwan, Turkey, and United Kingdom.
  • Descripción del producto
    ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline.
  • Modelo / Serial
    ADVIA 2120 Part No. 067-A012-01 (without Autosampler) and Part No. 067-A011-02 (with Autosampler); all ADVIA 2120 systems using Version 5 system software including Version 5.0.6 (Part No. 067-S045-06, English version), Version 5.1.1 (Part No. 067-S058-01, English version), and Version 5.2.7 (Part No. 067-S045-15, English version).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution-Domestic consignees consist of hospitals and clinical laboratories. Foreign countries (units): Canada (1), China (4), Singapore (1), Malaysia (2), Thailand (1), Taiwan (1), Vietnam (1), Australia (3), Korea (25), Japan (25), Israel (4), Saudi Arabia (4), Russia (1), Turkey (1), United Arab Emirates (1), South Africa (2), United Kingdom (31), Germany (1), Poland (9), Norway (1), Spain (48), Finland (7), Denmark (4), Portugal (14), Italy (5), Netherlands (3), France (46), Ireland (4), India (7), Austria (1).
  • Descripción del producto
    ADVIA 2120 systems -Automated Complete Blood Cell and Differential Cell Counter
  • Modelo / Serial
    Part No. 073-A010; all Advia Chemistry System units are serial numbers are involved in this ''field correction'' as well as existing assay lots for CARB, PHNY, GENT and DIG.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA and Puerto Rico.
  • Descripción del producto
    Advia 2400 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests.
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Más información acerca de la data acá

  • Dirección del fabricante
    Bayer Healthcare, LLC (Diagnostics Division), 511 Benedict Avenue, Tarrytown NY 10591
  • Source
    USFDA