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ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT Adverse Event — Malfunction (MDR 3005248192-2020-00003)

ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT Adverse Event — Malfunction (MDR 3005248192-2020-00003) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT; Generic name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID; Manufac

DeviceABBOTT REALTIME SARS-COV-2 AMPLIFICATION REAGENT KIT
Generic nameREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
ManufacturerABBOTT MOLECULAR, INC.
Report number3005248192-2020-00003
Event typeMalfunction
Product problemY
Date received2020-04-27
Report sourceCOMPANY REPRESENTATIVE
NarrativeELEVATED COMPLAINT INVESTIGATION HAS BEEN INITIATED.
SourceopenFDA MAUDE (device adverse events)

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