Events

Device Recall PerkinElmer Specimen Gate Screening Center 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
    79421
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1541-2018
  • 사례 시작날짜
    2017-11-17
  • 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=162274
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • 원인
    Potential errors in patient results generated by the screening center product that include both false negative and false positive results.
  • 조치
    PerkinElmer sent an Urgent Medical Device Correction letter dated November 14,2017. Instructions: 1. Implement additional control measures concerning demographic information, by taking one of the following actions a. Fully enter demographics before loading specimens on instruments (i.e. specimens can be punched, but the assay plates cannot be loaded to the measurement instruments). b. If the above mentioned is not possible or if previously entered demographic information changes after loading the assay plates on the measurement instruments, recalculate all your results in Specimen Gate laboratory Result Viewer prior to assay acceptance. 2. Follow unreported specimens with available tools to avoid any delay in reporting screening results. For further questions, please call (317) 418-1735

Device

Device Recall PerkinElmer Specimen Gate Screening Center
  • 모델명 / 제조번호(시리얼번호)
    All software versions from 1.0 to 1.8 (current software version)
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
  • 제품 설명
    Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) || Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
  • 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