2,061 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ARIES SARS-COV-2 ASSAY

FDA Adverse Event
Malfunction ·LUMINEX CORPORATION·Product code QJR·November 20, 2020

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·August 22, 2023

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 4, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·September 1, 2021

CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·September 10, 2021

CEPHEID XPERT XPRESS SARS-COV-2/FLU/RSV

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 6, 2021

T2SARS-COV-2 (EUA)

FDA Adverse Event
Malfunction ·T2 BIOSYSTEMS, INC·Product code QJR·June 14, 2022

ALINITY M RESP-4-PLEX AMP KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·November 13, 2024

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 6, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 30, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 30, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 8, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·September 1, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 30, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·July 28, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 25, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·August 24, 2021

CEPHEID XPERT XPRESS SARS-COV-2

FDA Adverse Event
Malfunction ·CEPHEID·Product code QJR·September 8, 2021

ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code QJR·December 6, 2021

COBAS® SARS-COV-2

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 19, 2022