Device Recall Specimen Gate Laboratory eReports

  • Model / Serial
    Software Version 1.0
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • Manufacturer Parent Company (2017)
  • Source
    USFDA