Events

NOVA Lite ANA KSL Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Inova Diagnostics Incorporated 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
    60219
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0280-2012
  • 사례 출판 날짜
    2011-11-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-04-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104801
  • 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
    in vitro diagnostic - Product Code DHN
  • 원인
    The nova lite ana ksl kit label has the wrong fill volume for the ifa system negative control (p/n 508186) with 1ml. the component in the kit is correctly labeled and filled with the 0.5ml fill volume.
  • 조치
    On 9/26/11, Inova Diagnostics forwarded an Urgent Advisory Notice and Product Advisory Notice Fax Back Form to all their customers who purchased the Nova Lite Ana KSL, Product Code: 708390. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete the attached fax back form indicating how many of these kits they have in their inventory, quantity destroyed, method of destruction and the quantity of kits that need to be replaced. Customers were also instructed to notify their customers of the advisory notice. Customers were instructed to contact Tana Keivens with any questions or comments at (858) 586-9900 ext 351.

Device

NOVA Lite ANA KSL Kit
  • 모델명 / 제조번호(시리얼번호)
    070409, 070491, 170069, 17014E1, 170214E2, 170440
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.
  • 제품 설명
    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit || Part Number: 708390. in vitro diagnostic.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • 제조사 주소
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA