FDA-Device2018-05-09Class II
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.
PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
Sold states
Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
Affected count
8
Manufactured in
Mustionkatu 6, P.O. Box 10, Turku, N/A, Finland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1541-2018Don't want to check this manually?
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