Events

Device Recall Luminex xTAG 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Luminex 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
    59345
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3112-2011
  • 사례 시작날짜
    2011-05-24
  • 사례 출판 날짜
    2011-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102337
  • 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
    Drug metabolizing enzyme genotyping systems - Product Code NTI
  • 원인
    Inaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.
  • 조치
    Luminex sent a "Customer Advisory" letter dated May 24, 2011, by email and courier 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 destroy any remaining product and to submit a return postcard to confirm that the consignee had been notified of the recall and had destroyed the product. For further questions please call Luminex Technical Support at 1-877-785-2323 ( US ) and 1-512-381-4397 ( Outside US ) Monday through Friday.

Device

Device Recall Luminex xTAG
  • 모델명 / 제조번호(시리얼번호)
    Kit Lot #: IK030B-0001 (US distribution) and Kit Lot # IK030B-1001 (European distribution)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA ( nationwide) and the countries of Belgium, UK and Canada.
  • 제품 설명
    xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 || The xTAG CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples.
  • Manufacturer
    Luminex Corporation

Manufacturer

Luminex Corporation
  • 제조사 주소
    Luminex Corporation, 12212 Technology Blvd, Austin TX 78727-6131
  • 제조사 모회사 (2017)
    Luminex Corporation
  • Source
    USFDA