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PerkinElmer Neonatal IVD Seizure Attributed To Poor Documentation

This article was originally published in The Gray Sheet

Executive Summary

Recent staff turnover at PerkinElmer's Norton, Ohio manufacturing site partly accounted for a failure to address QSR violations that prompted seizure of neonatal screening kits, according to the firm

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PerkinElmer will market its NeoGram amino acids and acylcarnitines tandem mass spectrometry (TMS) kit as a cost-effective alternative to laboratory blood testing for individual defects of metabolism among newborns

Neonatal Stand-Alone Screening Kit For Metabolic Disorders Cleared By FDA

PerkinElmer will market its NeoGram amino acids and acylcarnitines tandem mass spectrometry (TMS) kit as a cost-effective alternative to laboratory blood testing for individual defects of metabolism among newborns

PerkinElmer

Neonatal screening kits produced at the firm's Norton, Ohio plant are subject to additional FDA testing and labeling requirements, per a Feb. 13 agreement with the agency allowing the resumption of production. The plant is slated to shut in approximately six months, with all manufacturing to be consolidated at a Turku, Finland site. U.S. marshals seized nearly $1 mil. in kits Feb. 4, due to a lack of response to QSR violations (1"The Gray Sheet" Feb. 9, 2004, p. 16)...

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