ARCHITECT

  • Model / Serial
    ARCHITECT c4000 Cuvette Segment 02P75-01 Not applicable ARCHITECT c8000 Cuvette Segment 01G46-01 Not applicable ARCHITECT c16000 Cuvette Segment 09D32-05 Not applicable
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS

695 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product List Numbers, Lot Numbers, and Expiration Dates:   1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15;  2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.
  • Product Description
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: || - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. || - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. || The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
  • Manufacturer
  • Model / Serial
    ISR03967, ISR04737, ISR01461, ISR01998, ISR01964, ISR02446, ISR02751, ISR02781, ISR05266, ISR04520, ISR01460, ISR01442, ISR01988, ISR03034, ISR01194, ISR01583, ISR01955, ISR02437, ISR03144, ISR03352, ISR04369, ISR02360, ISR02361, ISR02842, ISR03495, ISR03756, ISR04244, ISR04420, ISR05155, ISR05240, ISR05242, ISR05433, ISR05671, ISR05883, ISR05946, ISR06050, ISR06054, ISR06837, ISR06864, ISR01696, ISR02073, ISR02264, ISR02269, ISR02999, ISR03668, ISR03901, ISR04053, ISR04165, ISR04388, ISR04586, ISR04619, ISR04770, ISR04773, ISR04775, ISR04801, ISR04996, ISR05202, ISR05662, ISR05732, ISR05751, ISR06406, ISR06592, ISR07108, ISR07240, ISR07741
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to France, Netherlands, Greece, Italy, Belgium, India, Austria, Germany, and Japan
  • Product Description
    ARCHITECT i2000SR System || The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
  • Manufacturer
  • Model / Serial
    Lot: 31497UN14 Exp.: 17 Oct. 2016; Lot: 09353UNI15 Exp.: 12 Feb. 2017; Lot: 45216UN15 12 May 2017; Lot: 14596UN15 Exp.: 30 Jul. 2017; Lot: 37055UN15 Exp.: 12 Oct. 2017; Lot: 14782UN16 Exp.: 21 Apr. 2018
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide Distribution.
  • Product Description
    ARCHITECT Lactic Acid Part # 09D891T21 || The Lactic Acid assay is used for the quantitation of lactic acid in human plasma.
  • Manufacturer
  • Model / Serial
    All serial numbers, List number 1G06-01
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and 21 foreign countries. Foreign countries: Mexico, Guatemala, Venezuela, Colombia, Ecuador, Chile, Uruguay, Argentina, Brazil, Puerto Rico, Jamaica, San Salvador, Canada, Germany, Singapore, China, Thailand, Australia, New Zealand, Panama, and Grand Cayman
  • Product Description
    ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
  • Manufacturer
  • Model / Serial
    list 02K43-01, lot number V96128
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Texas, Washington, Montana, Pennsylvania and Kentucky, and internationally to Korea
  • Product Description
    ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
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