FDA-Device2018-09-12Class III
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
Sold states
Distributed to CT and TX.
Affected count
240
Manufactured in
Mustionkatu 6, P.O. Box 10, Turku, N/A, Finland
Products
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2018Don't want to check this manually?
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