Devices

Device Recall PerkinElmer Specimen Gate Screening Center

  • Model / Serial
    All software versions from 1.0 to 1.8 (current software version)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
  • Product Description
    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
  • 1 Event

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY
  • Manufacturer Address
    PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
  • Manufacturer Parent Company (2017)
    Perkin Elmer Inc.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall PerkinElmer Specimen Gate Screening Center software
  • Model / Serial
    Product Code: 5002-0500; Software Versions, 1.4 and 1.6
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
  • Product Description
    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.