Events

JANUS Automated Workstation & JANUS G3 Automated Workstation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Perkinelmer Life Sciences, 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
    79015
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0728-2018
  • 사례 시작날짜
    2017-08-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161156
  • 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
    Station, pipetting and diluting, for clinical use - Product Code JQW
  • 원인
    We have become aware through internal testing that janus and janus g3 automated workstations were failing production final acceptance testing due to a horizontal motion error message displayed on the system. further investigation concluded that two printed circuit boards (pcb) used in mdt models of janus and janus g3 were manufactured with the incorrect resistor values. this anomaly affects component part number 7101640 (pcb-quad motor controller mdt) and part number 7101647 (pcb-quad motor controller gripper). this anomaly could result in the horizontal motion error being displayed and result in instrument down time. until perkinelmer s corrective measures are completed, we request you; ¿ be aware that there is potential for the horizontal motion error message to display which could result in instrument down time. ¿ follow guidance provided in the janus automated workstation user manual when the horizontal motion error message displays. ¿ if you have additional questions, contact perkinelmer technical support for further assistance (800) 762-4000.
  • 조치
    On August 4 2017 an URGENT Medical Device Correction letter titled "Horizontal Motion Error" was issued to customers informing them of the error notice and to follow guidance provided in the Janus Automated Workstation User Manual when the Horizontal Motion Error message displays. Question or concerns can be directed to Technical Support at 800-762-4000

Device

JANUS Automated Workstation & JANUS G3 Automated Workstation
  • 모델명 / 제조번호(시리얼번호)
    AJM4G01, AJL8001, AJI4G01, AJL8M01, CJM8M01, CJL8M01, CJL8001
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling instrument intended for use in clinical settings to facilitate the pipetting and dilution of solutions in sample preparation work flows.
  • Manufacturer
    Perkinelmer Life Sciences, Inc.

Manufacturer

Perkinelmer Life Sciences, Inc.
  • 제조사 주소
    Perkinelmer Life Sciences, Inc., 549 Albany St, Boston MA 02118-2512
  • 제조사 모회사 (2017)
    Perkin Elmer Inc.
  • Source
    USFDA