Events

Device Recall Roche/Hitachi Modular Analytics System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Corp. 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
    50171
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1065-2009
  • 사례 시작날짜
    2008-11-12
  • 사례 출판 날짜
    2009-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74893
  • 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
    Chemistry Analyzer for Clinical Use - Product Code JJE
  • 원인
    If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.
  • 조치
    Consignees were notified via an Urgent Medical Device Correction letter dated 11/12/08 and instructed to only execute "module unmasking" when the unit is in "standby" mode and to consult with their physicians at the facility to determine the clinical implications and whether any clinical intervention is needed for patients treated based upon results obtained with this software. Questions should be directed to Roche Diagnostics Technical Support at 1-800-428-2336.

Device

Device Recall Roche/Hitachi Modular Analytics System
  • 모델명 / 제조번호(시리얼번호)
    All units with software version 08-03.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- including states of California, Florida, Georgia, Hawaii, Indiana, Maryland, New York, North Carolina, Pennsylvania, and Virginia.
  • 제품 설명
    Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roche Diagnostics Corp., Indpls., IN; GMMI No. 03284549001. || Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • 제조사 주소
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA