Events

Device Recall Minutex DDimer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tcoag Us, 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
    59957
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0030-2012
  • 사례 시작날짜
    2011-06-13
  • 사례 출판 날짜
    2011-10-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104078
  • 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
    Fibrin split products - Product Code GHH
  • 원인
    There is a performance issue with minutex d-dimer kit which may cause false negative results for patient samples containing levels of greater than 250ng/ml d-dimer.
  • 조치
    The firm,Tcoag US, Incorporated, sent an "Urgent Device Recall" letter dated June 13, 2011 via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products subject to recall; complete and return the attached Product Recall Notification Response Form by June 22, 2011 via fax at 973-775-3085; scrap the products consistent with their laboratory policy and if they have further distributed these products, notify their customers to quarantine and scrap the recalled product. For questions or technical assistance, please call the Tcoag hotline at 1-888-291-0415, option 2 (7.30 am to 6.00 pm Eastern Time).

Device

Device Recall Minutex DDimer
  • 모델명 / 제조번호(시리얼번호)
    510 K number: K920668  Device listing number: D099358 Lot Numbers: Expiry Date: C040002 10 July 2012 C042002 14 Jan 2012 B218005 05 Jan 2012 B341002 03 May 2012 B144001 30 Sept 2011
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • 제품 설명
    Minutex D-Dimer ; Trinity Biotech plc, || Bray, || Co. Wicklow, || Ireland. || Tel: (353) 1 276 9800, || Fax: (353) 1 276 9888, || Web: www.trinitybiotech.com || Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.
  • Manufacturer
    Tcoag Us, Incorporated

Manufacturer

Tcoag Us, Incorporated
  • 제조사 주소
    Tcoag Us, Incorporated, 330 Waterloo Valley Rd, Budd Lake NJ 07828-1395
  • Source
    USFDA