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
    79649
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1480-2018
  • 사례 시작날짜
    2018-02-08
  • 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=162895
  • 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 lower concentration of the rna panel could cause a no call or false negative for the reporting of ros1 fusion. if a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
  • 조치
    The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to vineet.bansal1@thermofisher.com. Questions and comments should be directed to Vineet Bansal, 408-802-2341, vineet.bansal1@thermofisher.com.

Device

Device Recall Oncomine Dx Target Test
  • 모델명 / 제조번호(시리얼번호)
    Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Distributed to states: AZ, CA, NC, TX, and VA.
  • 제품 설명
    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). || A qualitative In Vitro Diagnostic test.
  • 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