Ortho data on Summit pipettor software interface deficient -- FDA warning letter.
This article was originally published in The Gray Sheet
ORTHO DATA ON SUMMIT PIPETTOR SOFTWARE INTERFACE DEFICIENT FDA says in an Oct. 11 FDA warning letter to Ortho Diagnostic Systems. Stemming from a June 24 through Aug. 7 FDA inspection of Ortho's Raritan, New Jersey-based facilities, the warning letter says that the firm "lacks complete information regarding procedures and device specifications for the Summit" automated blood sample handling instrument "as it interfaces with applied software."
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