Abbott Laboratories

2 devices in the database

  • Model / Serial
    Product Control/Lot # 9274912, (Exp. Date: 8/31/2003) Product Control/Lot # 9275012, (Exp. Date: 8/31/2003) Product Control/Lot # 9275212, (Exp. Date: 8/31/2003)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentina, Canada and Puerto Rico.
  • Product Description
    Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System CELL-DYN REAGENT || Model/List Number 01H73-01
  • Model / Serial
    All lots of 9402212 and ALL lower numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 428 consignees in U.S. and 17 foreign consignees. The U.S. States include: AL, AZ, CA, CO, FL, GA, IA, MN, MO, NY, NC, SC, TN, TX and UT; and foreign accounts include: Argentina, Canada and Puerto Rico. Product was distributed to 10 U.S. Government accounts: (1) AK Native Med Center Supply 4315 Diplomacy Dr. Anchorage, AK 99508 907-729-1200 (2) Walter Reed Army Medical 6900 georgia Ave. NW Washington DC 20307 202-782-2579 (3) WHMC Medical material Mgr. 2200 Bergquest Dr. lackland AFB, TX 78236 (210)-670-7505 (4) DD Eisenhower AMC PAT E. Hospital Rd. Fort Gorden, GA 80220 (706) 791-2430 (5) VA Medical Center 1055 Claremont St. Denver, CO 80220 (303) 399-8020 (6) VA Hospital Supply 500 Foothill Dr. Salt Lake City, UT 84148 (801) 584-1248 (7) WHMC Medical Material Mgr. 2200 Bergquist Dr. Lackland AFB, TX 78236 (210) 670-7505 (8) VA Medical Center 650 E. Indian School Rd. Phoenix, AZ 85012 (602) 277-5551 (9) VA Medical Center 109 Bee St. Charleston, SC 29401 (843) 577-5011 (10) USPHS Phoenix 4212 N. 16th St. Phoenix, AZ 85016 (602) 263-1585
  • Product Description
    Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System || CELL-DYN REAGENT PART A || Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)

110 manufacturers with a similar name

Learn more about the data here

  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
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