Events

Device Recall Perkin Elmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PerkinElmer Life and Analytical Sciences, Wallac, OY 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
    61031
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1116-2012
  • 사례 시작날짜
    2012-01-09
  • 사례 출판 날짜
    2012-02-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107141
  • 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
    Gsp instruments with defective washer modules may cause a false negative screening result being reported for t4, tsh and irt. for 17-ohp, a false positive result may be generated if the failure occurs for a normal sample.
  • 조치
    Perkin Elmer issued an "Urgent Medical Device Recall" letter dated 1/25/12 to all customers and informed them about the possible issue and requested permission for service personnel to check their instrument. The customers were instructed that the instrument could not be used and the washer module required replacement. Customers were told to expect to be contacted by the firm's local representative for further details.

Device

Device Recall Perkin Elmer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers from 20210012 to 20210021
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA, including the states of Florida, Ohio, Oregon, Texas and the countries of Brazil, Belgium, France, Germany, and the UK.
  • 제품 설명
    Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids.
  • Manufacturer
    PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • 제조사 주소
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • 제조사 모회사 (2017)
    Perkin Elmer Inc.
  • Source
    USFDA