Events

Device Recall AmpliChip CYP450 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
    37585
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0734-2007
  • 사례 시작날짜
    2007-03-09
  • 사례 출판 날짜
    2007-04-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-08-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50895
  • 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 System - Product Code NTI
  • 원인
    The current package insert for the amplichip cyp 450 test, lists an incorrect part number for dnase i. the dnase is listed in the "other materials required" section as 'dnase i rec., rnase-free, p/n 04716728001 (roche applied science)" . the part number listed for the dnase i listed is incorrect and of lower specific activity than the correct/validated dnase.
  • 조치
    A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.

Device

Device Recall AmpliChip CYP450
  • 모델명 / 제조번호(시리얼번호)
    US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary
  • 제품 설명
    AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA