FDA-Device2015-11-04Class II
Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Perkin Elmer Life Sciences Inc
Hazard
It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect.
Sold states
US distribution to FL, GA, and NV; and Canada
Affected count
6 units
Manufactured in
Laitun 4 Mustionkatu 6, N/A, Turku, N/A, Finland
Products
Perkin Elmer Specimen Gate, Screening Center. 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-0166-2016Don't want to check this manually?
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