Events

Device Recall Factor V Leiden Kit; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Molecular Systems, 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
    58747
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2566-2011
  • 사례 시작날짜
    2011-03-31
  • 사례 출판 날짜
    2011-06-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100216
  • 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
    Test, factor v leiden mutations, genomic dna pcr - Product Code NPQ
  • 원인
    Roche molecular systems has decided to discontinue marketing the factor ii (prothrombin) g20210a kit and the factor v leiden kit for use with the light cycler 2.0 instrument in the us market.
  • 조치
    Roche sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 31, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The customer was instructed to discontinue use of the affected product by August 31, 2011. Complete the attached faxback form ( 4293-00-0311 ) and fax it to 1-888-345-5359. For questions or technical support, please contact Roche Molecular at 1-800-526-1247,

Device

Device Recall Factor V Leiden Kit;
  • 모델명 / 제조번호(시리얼번호)
    Lot Number Expiration 12659020 30-Sep-2007 13014720 31-Jan-2008 13368720 31-Jul-2008 13368820 31-Jul-2008 13462420 30-Sep-2008 13749620 31-Jan-2009 13793120 31-Jan-2009 14066220 31-May-2009 14447220 30-Jun-2009 14172920 30-Sep-2009 14692620 31-Dec-2009 14692621 31-Dec-2009 10964020 30-Sep-2010 11242120 31-Jan-2011 11666730 31-May-2011 11965420 30-Sep-2011 12180320 31-Dec-2011 12433020 30-Apr-2012
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001. || For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler¿ 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler¿ 2.0 Instrument using the LightCycler¿ Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 South, Somerville NJ 08876-3733
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA