Devices

Device Recall ARCHITECT Reaction Vessel

  • 모델명 / 제조번호(시리얼번호)
    Product Number: 7C15-01; Lot Numbers: 68446P100, 69061P100, 69283P100, 68487P100, 69063P100, 69284P100, 68488P100, 69082P100, 69340P100, 68489P100, 69176P100, 69341P100, 68491P100, 69177P100, 69342P100, 68492P100, 69178P100, 69353P100, 68511P100, 69179P100, 69433P100, 68513P100, 69180P100, 69434P100, 68515P100, 69205P100, 69435P100, 68516P100, 69206P100, 69436P100, 68553P100, 69207P100, 69438P100, 69006P100, 69208P100, 69439P100, 69007P100, 69209P100, 69521P100, 69008P100, 69266P100, 69522P100, 69009P100, 69267P100, 69523P100, 69010P100, 69280P100, 69526P100, 69058P100, 69281P100, 69527P100, 69060P100, 69282P100 and 69660P100, 68306P100, 68389P100, 68390P100, 68391P100, 68392P100, 68393P100, 69684P100, 73657P100, 73742P100, 74114P100, 74115P100, 74117P100, 74235P100, 74277P100 and 74283P100.  The recall was expanded to include an additional 40 lots on 12/7/09: 62616P100, 62756P100, 65386P100, 65388P100, 65740P100, 68007P100, 68097P100, 68119P100, 68241P100, 69683P100, 69686P100, 70421P100, 70431P100, 70563P100, 70565P100, 70598P100, 70601P100, 71077P100, 71092P100, 71168P100, 71234P100, 71235P100, 71239P100, 71304P100, 71447P100, 71448P100, 71450P100, 71451P100, 71515P100, 71519P100, 71550P100, 71554P100, 71555P100, 71558P100, 72252P100, 72293P100, 73319P100, 73464P100, 78387P100, and 80275P100.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kong, Taiwan, Thailand, South Korea, Uruguay, Austria, Bahrain, Belarus, Belgium, Bosnia & Herzegovia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, India, Indonesia, Ireland, Italy, Jamaica, Kuwait, Luxembourg, Malaysia, Netherlands, Norway,Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Zimbabwe and Australia.
  • 제품 설명
    ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. || The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.
  • Manufacturer
    Abbott Laboratories
  • 1 Event

제조사

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “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
    USFDA