Events

Device Recall ARCHITECT Reaction Vessel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    51254
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1392-2009
  • 사례 시작날짜
    2009-02-26
  • 사례 출판 날짜
    2009-05-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-11-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79476
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of architect reaction vessels.
  • 조치
    Consignees were contacted by phone and sent an "Urgent Field Safety Notice Product Recall" dated February 26, 2009. The letter informed users of the problem and detailed how to identify and discard the affected product. In addition, Abbott Laboratories asked the consignees to send a copy of the letter to any laboratory to which they may have forwarded any of affected lots. Abbott sent a second letter dated May 12, 2009 informing consignees of a recall expansion of additional affected lots. The recall was again expanded on 12/17/09 for an addtional 40 lots of reaction vessels. For additional information, contact Abbott Labs at 1-877-4ABBOTT.

Device

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

Manufacturer

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