Events

Device Recall STRATIFY JCV DxSelect 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Focus Diagnostics 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
    70856
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1454-2015
  • 사례 시작날짜
    2015-03-15
  • 사례 출판 날짜
    2015-04-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135234
  • 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
    Anti-jcv antibody detection assay - Product Code OYP
  • 원인
    Focus diagnostics is recalling the stratify jcv dx select due to the use of a non-conforming batch in the manufacture of jcv dxselect el1950 kit lot #27333. this could lead to a potential for false positive jcv results.
  • 조치
    Focus Diagnostics sent an Urgent Device Customer Notification letter dated March 15, 2015, was sent to the customer to inform them that Focus Diagnostics is recalling the Stratify JCV DxSelect (EL1950) lot#27333 due to the potential for false positive JCV results. The letter informs the customer of the issues and the actions to be taken. The customer is instructed to complete the enclosed acknowledgement form and email the form to DxTS@focusdx.com or fax back to Focus Diagnostics Technical Services at (562) 240-6526 within 10 business days. If the customer has any questions or require additional information, then they are instructed to contact Focus Diagnostic's Technical Services department at (800) 838-4548, select option 3, between the hours of 7am to 5pm (PST) or send an email to DxTS@focusdx.com.

Device

Device Recall STRATIFY JCV DxSelect
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 27333
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Internationally: Denmark only.
  • 제품 설명
    STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic.
  • Manufacturer
    Focus Diagnostics Inc

Manufacturer

Focus Diagnostics Inc
  • 제조사 주소
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA