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PerkinElmer Life and Analytical Sciences, Wallac, OY recalls AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunor
Recalled September 12, 2018 · FDA recall Z-1220-2018 · 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. · FDA Class III
Units
240
Sold at
Distributed to CT and TX.
Description
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.
Product
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
Manufacturer(s)
PerkinElmer Life and Analytical Sciences, Wallac, OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →