Events

Device Recall Bond Elut Dried Matrix Spotting (DMS) cards 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Agilent Technologies, Inc. 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
    76698
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1737-2017
  • 사례 시작날짜
    2015-06-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153930
  • 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
    Newborn screening specimen collection paper - Product Code PJC
  • 원인
    The product was marketed without 510(k) clearance.
  • 조치
    Agilent Technologies Letters via e-mail were sent to customers on June 17, 2015. Letters advised that the Bond Elut DMS Product was being withdrawn from the market.

Device

Device Recall Bond Elut Dried Matrix Spotting (DMS) cards
  • 모델명 / 제조번호(시리얼번호)
    All
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US and Australia, Thailand, Great Britain, Germany, Japan, Netherlands, France, Taiwan, Canada, South Africa, China, Slovenia, Spain, Italy, Norway, India, Russia, Finland, Czech Republic, Singapore, Denmark, Korea, Ireland, United Arab Emirates, .Belgium, Switzerland and Sweden.
  • 제품 설명
    Bond Elut OMS (Dried Matrix Spotting)' Product; || Catalog model numbers: || 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; || A400150 - Bond Elut EMS Card 50/Pk; || A400150K - Bond Elut DMS Card BULK 500/pk; || A400150SK - Bond Elut DMS Card Starter Kit || A42001 - Bond Elut MDS Card Accessory Pack || Product Usage: For use in the analysis of dried blood spots and other || biological matrices in research applications for drug || metabolism pharmacokinetics/ absorption, distribution. || metabolism and excretion (DMPK/ ADME) studies.
  • Manufacturer
    Agilent Technologies, Inc.

Manufacturer

Agilent Technologies, Inc.
  • 제조사 주소
    Agilent Technologies, Inc., 5301 Stevens Creek Blvd, Santa Clara CA 95051-7201
  • 제조사 모회사 (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA