Events

Device Recall ABX PENTRA 400C 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Horiba Instruments 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
    73349
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1554-2016
  • 사례 시작날짜
    2016-02-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-08-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143930
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Horiba instruments, inc. is recalling abx pentra 400( version 5.0.8 or lower) and pentra c400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
  • 조치
    HORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part of laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days, in order to verify understanding of it. Any questions or concerns contact the local Horiba Medical representative. For further questions, please call (949) 250-4811.

Device

Device Recall ABX PENTRA 400C
  • 모델명 / 제조번호(시리얼번호)
    All lot/serial #s
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
  • 제품 설명
    Pentra C400 (version 1.1.2 or lower) || The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
  • Manufacturer
    Horiba Instruments Inc

Manufacturer

Horiba Instruments Inc
  • 제조사 주소
    Horiba Instruments Inc, 9755 Research Dr, Irvine CA 92618-4626
  • 제조사 모회사 (2017)
    Horiba Ltd.
  • Source
    USFDA