Events

ARCHITECT iVancomycin Reagent 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
    56757
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0629-2011
  • 사례 시작날짜
    2010-09-13
  • 사례 출판 날짜
    2010-12-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-06-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94458
  • 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
    Calibrators, drug specific - Product Code DLJ
  • 원인
    The assay may produce falsely elevated vancomycin results. inaccurate test results may result in inappropriate patient treatment.
  • 조치
    Abbott Laboratories issued a Product Correction letters dated September 13 and 15, 2010 to all customers that received ARCHITECT iVancomycin reagents in the last 12 months. In the September 13, 2010 letter, the accounts were informed of the falsely elevated results and were instructed to continue to follow all sample handling instruction in the package insert and to take the following additional actions to mitigate the risk of obtaining an incorrect result: 1. After following the primary tube manufacturer's recommended centrifugation instructions transfer serum or plasma for all specimens to a microcentrifuge tube for centrifugation at 150,000-300,000 g-minutes, following centrifugation guidelines in the chart in the letter. 2. Prior to testing, transfer the serum or plasma to a sample cup or secondary tube for testing. Care must be taken to transfer only the clarified specimen and not the lipemic material or pellet. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. On September 15, 2010, Abbott discovered that the calculation for the determination of RCF (xg) given in the September 13, 2010 letter was incorrect. Incorrect Calculation previously provided: Relative Centrifugal Force (RCF) = 0.0000118 x rotational radius in centimeters x RPM2 Correct Calculation within revised letter: Relative Centrifugal Force (RCF) = 0.00001118 x rotational radius in centimeters x RPM2 Abbott stopped distribution of the previous letter and initiated redistribution of the revised letter to all impacted customers, globally, on September 15, 2010. Additionally, all customers which had already received the initial letter were sent a cover letter identifying the error. Customers can contact Abbott at 1-877-422688 about this action.

Device

ARCHITECT iVancomycin Reagent
  • 모델명 / 제조번호(시리얼번호)
    list 1P30-25, all lots
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Throughout USA, including Puerto Rico, and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom and Vietnam.
  • 제품 설명
    ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25 || The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate 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