Events

Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Tosoh Bioscience 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
    78776
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0491-2018
  • 사례 시작날짜
    2017-06-11
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160396
  • 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
    Fluorometer, for clinical use - Product Code KHO
  • 원인
    This recall has been initiated due to a potential malfunction of the photo interrupter (pl). the potential malfunction has been attributed to aging and premature deterioration of the pl collector current.
  • 조치
    Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery.

Device

Device Recall Tosoh Automated Enzyme Immunoassay Analyzer AIA900
  • 모델명 / 제조번호(시리얼번호)
    All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - U.S. Nationwide - Latin America
  • 제품 설명
    Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. || Product Usage: || The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
  • Manufacturer
    Tosoh Bioscience Inc

Manufacturer

Tosoh Bioscience Inc
  • 제조사 주소
    Tosoh Bioscience Inc, 3600 Gantz Rd, Grove City OH 43123-1895
  • 제조사 모회사 (2017)
    Tosoh Corp.
  • Source
    USFDA