Events

Device Recall Specimen Gate Laboratory eReports 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
    75817
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0902-2017
  • 사례 시작날짜
    2016-12-01
  • 사례 출판 날짜
    2016-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151383
  • 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
    Issue may cause ereports to consume an excessive amount of disk space causing the software to stop operating.
  • 조치
    PerkinElmer Health Sciences issued a Medical Device Correction letter dated December 1, 2016, to all affected customers email facilitated through our PerkinElmer Software Services group located in Akron Ohio. Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures. Actions to be taken A field correction of the issue is recommended. PerkinElmer will correct the issue with an update installed through remote connection. You will be contacted by your PerkinElmer representative to make the necessary arrangements for implementing the update. In the interim period, please do not attempt to login multiple times in quick succession. Allow the software time to respond to first login command. Please contact your local PerkinElmer representative or Specimen Gate Support for further information. Other Information Please inform those affected in your organization accordingly. To comply with regulatory requirements we request that you complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 22, 2016. For questions regarding this recall call 781-663-6900.

Device

Device Recall Specimen Gate Laboratory eReports
  • 모델명 / 제조번호(시리얼번호)
    Software Version 1.0
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
  • 제품 설명
    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 || Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
  • 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