Events

DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Euro Diagnostica AB 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
    79183
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0929-2018
  • 사례 시작날짜
    2015-10-15
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161552
  • 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
    Antinuclear antibody, antigen, control - Product Code LKJ
  • 원인
    Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the elisa plate, the strong igm conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two fana200 kit lots ss 1500 and ss 2009.
  • 조치
    Euro Diagnostica sent a Customer notifications letter to affected customers via email on 10/15/2015. The letter identified the affected product problem and actions to be taken. For question contact Euro Diagnostica .

Device

DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA
  • 모델명 / 제조번호(시리얼번호)
    UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and US. Nationwide
  • 제품 설명
    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. || Product Usage: || The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
  • Manufacturer
    Euro Diagnostica AB

Manufacturer

Euro Diagnostica AB
  • 제조사 주소
    Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
  • 제조사 모회사 (2017)
    C&P Investors Limited
  • Source
    USFDA