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Home » FDA 483 Raps Beckman Coulter for Lax MDR Reporting, GMPs
FDA 483 Raps Beckman Coulter for Lax MDR Reporting, GMPs
September 1, 2011
Beckman Coulter filed incomplete medical device reports (MDRs) on its reagents and analyzers — and in numerous cases failed to file MDRs at all — despite physician concerns that its devices were producing erroneous results, according to an FDA Form 483.