Events

Device Recall HSV2 Primers 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Life Technologies Corporation 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
    65770
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2085-2013
  • 사례 시작날짜
    2013-05-13
  • 사례 출판 날짜
    2013-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120130
  • 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
    Bacteriophage and controls, b. Anthracis lysis - Product Code NYQ
  • 원인
    Firm received complaints that hsv-2 primers failed to amplify hsv-2 dna.
  • 조치
    Life Technologices sent an Urgent Product Recall letter dated May 13, 2013 by certified mail to all affected customers. The letter identified the product, description of problem, and actions to be taken by the user. Customers were instructed to examine inventory immediately, discontinue use and dispose all affected units. Customers were advised to complete the Customer Response Sheet included for product/quantities consumed, and send e-mail to techsupport@lifetech.com. For questions about the details of this product issue, were instructed to contact Technical Support at 800-955-6288 option 4.

Device

Device Recall HSV2 Primers
  • 모델명 / 제조번호(시리얼번호)
    Catalog #18081020, Lot #1368760 & Lot #1312093
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of DE, IA, MN, and NC.
  • 제품 설명
    HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • 제조사 주소
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA