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PerkinElmer Life and Analytical Sciences, Wallac, Recall: AutoDELFIA Neonatal immunoreacti

PerkinElmer Life and Analytical Sciences, Wallac, Recall: AutoDELFIA Neonatal immunoreacti is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: PerkinElmer Life and Analytical Sciences, Wallac, OY; Product: AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantit

Recalling firmPerkinElmer Life and Analytical Sciences, Wallac, OY
ProductAutoDELFIA 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
Reason for recallThe 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.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionDistributed to CT and TX.
Recall initiated20170925
Recall numberZ-1220-2018
Categorydevice
StateN/A
CountryFinland

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