Events

Device Recall PerkinElmer Specimen Gate Screening Center software 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PerkinElmer Health 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
    68670
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2166-2014
  • 사례 시작날짜
    2014-06-27
  • 사례 출판 날짜
    2014-08-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128489
  • 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 for demographic information and test result to be mismatch.
  • 조치
    PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email specimen.gate.support@perkinelmer.com. Customers with questions were instructed to call 1-800-321-9632. option 1.

Device

Device Recall PerkinElmer Specimen Gate Screening Center software
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 5002-0500; Software Versions, 1.4 and 1.6
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
  • 제품 설명
    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 || Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
  • Manufacturer
    PerkinElmer Health Sciences, Inc.

Manufacturer

PerkinElmer Health Sciences, Inc.
  • 제조사 주소
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • 제조사 모회사 (2017)
    Perkin Elmer Inc.
  • Source
    USFDA