Events

IsMumps IgG 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Diamedix 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
    73694
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1685-2016
  • 사례 시작날짜
    2014-10-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144767
  • 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
    Enzyme linked immunoabsorbent assay, mumps virus - Product Code LJY
  • 원인
    A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.
  • 조치
    The firm, Diamedix, sent letters dated October 14, October 20 and December 5, 2014 to its customers directly informing them of the correction action. Notification of all domestic customers via Certified Mail. Notification fo the international customers via Federal Express and/or e-mail. With the letter, a replacement bottle of Sample B Diluent was sent and the customer was advised to discard any unused bottles of affected product. New lot number labels were provided to identify kits with the replacement Sample B Diluent. Customers with questions were told they could contact Diamedix Technical Services (1-800-327-4565) if they had any questions or required any additional guidance regarding the correction.

Device

IsMumps IgG
  • 모델명 / 제조번호(시리얼번호)
    Lot # 20804, Catalog # 720-540. Expiration Date August 31, 2015
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US nationwide including states of: AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Puerto Rico. and Country of: ITALY.
  • 제품 설명
    Diamedix Is-Mumps IgG Test Kit || Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • 제조사 주소
    Diamedix Corporation, 14100 Nw 57th Ct, Miami Lakes FL 33014-3107
  • 제조사 모회사 (2017)
    Diamedix, Inc.
  • Source
    USFDA