Events

Roche Molecular Diagnostics Inc. 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
    74221
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2254-2016
  • 사례 시작날짜
    2016-04-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146849
  • 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
    Somatic gene mutation detection system - Product Code OWD
  • 원인
    During internal studies using contrived plasma specimens, several mutations (l8568r, exon 19 deletion, t790m) inconsistently generated "no mutation detected" (ie false negative ) result with the cobas egfr mutation text v2.0 when utilizing the cobas cfdna sample preparation kit.
  • 조치
    Roche Molecular Diagnostics sent an Urgent Field Safety Notice letter dated April 5, 2016 to affected customers. Then letter identified the affected product, problem and actions to be taken. The Instructions for use are provided for the user until new ones are available..

Device

Roche Molecular Diagnostics Inc.
  • 모델명 / 제조번호(시리얼번호)
    Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Foriegn Distribution Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom cfDNA: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom
  • 제품 설명
    cobas EGFR Mutation Test V2 || Materials number || CE-IVD: EGFR v2: 07248563190 || cfDNA: 07247737190 || Device Identifier: || EGFR v2.0: 00875197005448 || cfDNA: 00875197005424 || Product Usage: || A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

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