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
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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