Events

Device Recall Oncomine Dx Target Test 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Life Technologies Corporation 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
    79437
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1279-2018
  • 사례 시작날짜
    2017-12-04
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162327
  • 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
    Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
  • 원인
    The oncomine dx target test may report erroneous results when used off-label for samples other than non-small cell lung cancer (nsclc) tumor specimens.
  • 조치
    The following actions are described in the consignee later: Review your testing results from the Oncomine Dx Target Test to ensure that none of the reports containing BRAF V600E positive samples are impacted. Utilize Figure 1 and 2 to aid in identifying this discrepancy. If you have any questions, please contact 408.802.2341.

Device

Device Recall Oncomine Dx Target Test
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017)  UDI: (01)10190302006071
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of: AZ, CA, NC, TX, and VA.
  • 제품 설명
    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 || The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • 제조사 주소
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA