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
    All Serial Numbers: ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.
  • Product Description
    ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
  • Manufacturer
  • Model / Serial
    All Serial Numbers--ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.
  • Product Description
    ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
  • Manufacturer
  • Model / Serial
    LIst 6E59, Versions 22.0 and below, Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100, 54701P100, 50449P100, 52151P100, 54692P100
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Only: Australia, Canada, Chile, Costa Rica, Dominican Republic, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Thailand, Uruguay and Venezuela. There were no USA accounts.
  • Product Description
    ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA
  • Manufacturer
  • Model / Serial
    Lot Number: 82520M.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Arizona, California, Florida, Illinois, Kansas, Louisiana, Massachusetts, Missouri, Montana, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah and Virginia.
  • Product Description
    Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064. || ARCHITECT LH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the LH assay on the Abbott ARCHITECT i System.
  • Manufacturer
  • Model / Serial
    List numbers 5F48-22 and 5F48-23, part numbers 7-204717-01 and 7-204717-02 when used with 7-94255-01 and 7-200788-01.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide.
  • Product Description
    ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. || The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology.
  • Manufacturer
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