Events

Device Recall Factor II (Prothrombin) G20210A 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-2565-2011
  • 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=100215
  • 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
    Prothrombin-proconvertin and thrombotest - Product Code JPF
  • 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 II (Prothrombin) G20210A Kit
  • 모델명 / 제조번호(시리얼번호)
    Lot Number Expiration 12658920 30-Sep-2007 13065720 31-Mar-2008 13218920 31-May-2008 13412020 31-Aug-2008 13462320 30-Sep-2008 13560320 31-Oct-2008 13736420 31-Jan-2009 13990720 31-Mar-2009 14066120 31-May-2009 14172820 31-Jul-2009 14172821 31-Jul-2009 14674120 31-Dec-2009 14837220 28-Feb-2010 10963920 30-Sep-2010 11242020 31-Jan-2011 11333523 31-Jan-2011 11509420 30-Apr-2011 11509520 30-Apr-2011 11928321 30-Sep-2011 11928420 30-Sep-2011 12180220 30-Nov-2011 12181020 31-Dec-2011
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument; || The Factor II (Prothrombin) G20210A Kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene 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 II DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (Prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A 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 Roche Confidential Page 3 of 9 LightCycler¿ Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.tributed by Roche Diagnostics Indianapolis, IN 46256 USA; 03610195001
  • 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