Events

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit 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
    72395
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0238-2016
  • 사례 시작날짜
    2015-10-02
  • 사례 출판 날짜
    2015-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140907
  • 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
    Research use only/microbiology - Product Code OTT
  • 원인
    Focus diagnostics is recalling the anaplasma phagocytophilum ifa igm kit because of the potential increase in invalid results.
  • 조치
    A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011. The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors. Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PST) or send an email to DxTS@focusdx.com.

Device

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit
  • 모델명 / 제조번호(시리얼번호)
    26341, 27011
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
  • 제품 설명
    Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M 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