Events

Device Recall Ebola Virus Antigen Nasal 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lusys Laboratories, 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
    70668
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1333-2015
  • 사례 시작날짜
    2015-03-13
  • 사례 출판 날짜
    2015-04-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134410
  • 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
    virus test kit - Product Code N/A
  • 원인
    Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
  • 조치
    LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688. For questions regarding this recall call 858-546-0902.

Device

Device Recall Ebola Virus Antigen Nasal
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 12292014B
  • 유통
    Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
  • 제품 설명
    Ebola Virus Antigen Nasal , Catalog No. I-123 (B) || Materials Provided: || 1. Test Device in foil pouch. || 2. Lancet for Blood test and alcohol pad. || 3. Extraction tube contain buffer vial(0.5ml) for feces test || 4. Swab for Nasal test.
  • Manufacturer
    Lusys Laboratories, Inc.

Manufacturer

Lusys Laboratories, Inc.
  • 제조사 주소
    Lusys Laboratories, Inc., 10054 Mesa Ridge Ct Ste 118-120, San Diego CA 92121-2946
  • 제조사 모회사 (2017)
    Lusys Laboratories Inc
  • Source
    USFDA