Events

ARCHITECT Cyclosporine 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
    60094
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0162-2012
  • 사례 시작날짜
    2011-10-07
  • 사례 출판 날짜
    2011-11-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-11-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104415
  • 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
    Cyclosporine - Product Code MKW
  • 원인
    The architect cyclosporine assay has the potential to generate falsely elevated or depressed results with patient samples due to precision exceeding the package insert claim of <15% total cv. calibrators and controls also have the potential to be impacted by the assay imprecision.
  • 조치
    Abbott Laboratories sent a "PRODUCT RECALL" letter dated October 7, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to only run ARCHITECT Cyclosporine using Reaction Vessel (RV) lots manufactured with the same resin as follows: a) RV lots beginning with lot 06083P100 and higher can be used together or, b) RVs lots lower than 06083P100 can be used together. Any RV lot number that does not begin with a zero (e.g. 90032P100) should also be considered lower than 06083P100. Further instructions were included for the accounts to follow when running ARCHITECT Cyclosporine assays. A Customer Reply form was provided to customers to complete and return via fax at 1-800-777-0051. Customers can contact Abbott Customer Service at 1-877-4ABBOTT for questions regarding this notice. A second letter was sent to the accounts on 11/23/11 to simplify the instructions for identifying the Architect Reaction Vessel lots that can be used together for use with the Architect Cyclosporine assay.

Device

ARCHITECT Cyclosporine
  • 모델명 / 제조번호(시리얼번호)
    lots 95098M500 exp 12/21/2011; 96143M500 exp 01/20/2012; 96142M500 exp 01/20/2012; 01107M500 exp 02/24/2011; 02079M500 exp 02/24/2012; 03182M500 exp 05/19/2012; 05533M500 exp 05/19/2012; 04069M500 exp 06/02/2012; 06525M500 exp 06/02/2012; 05014M500 exp 06/23/2012; 07011M500 exp 06/23/2012
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
  • 제품 설명
    ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1L75-25. || The ARCHITECT Cyclosporine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood on the ARCHITECT i System. The ARCHITECT Cyclosporine assay is used as an aid in the management of heart, liver and kidney transplant patients receiving cyclosporine therapy.
  • 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