32 results
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141ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Malfunction
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SENSITITRE GRAM NEGATIVE IVD AST SENSITITRE PLATE
FDA Adverse Event
Malfunction
·TREK DIAGNOSTIC SYSTEMS, LTD.·Product code JWY·December 5, 2024
3T
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DWC·May 4, 2017
VENIPUNCTURE NEEDLE-PRO DEVICE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JKA·April 8, 2009
COVID-19 AT-HOME TEST
FDA Adverse Event
Malfunction
·SD BIOSENSOR, INC.·Product code QKP·December 28, 2022
PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code MMW·February 9, 2012
PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code MMW·February 9, 2012
PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code MMW·January 16, 2012
PROBECHEK UROVYSION CONTROL SLIDES
FDA Adverse Event
Malfunction
·ABBOTT MOLECULAR, INC.·Product code MMW·May 20, 2011
COBAS(R) TAQSCREEN MPX TEST FOR USE ON THE COBAS S 201 SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS·Product code MZP·January 26, 2010
RESPIRONICS
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNT·May 20, 2025
ACCESS SARS-COV-2 IGM
FDA Adverse Event
Malfunction
·CLARE DISCRETE MFG IO·Product code QKO·April 23, 2021
ELECSYS SYPHILIS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LIP·October 15, 2025
ELECSYS HIV COMBI PT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MZF·September 24, 2025
VIROTROL I, CLASS F
FDA Adverse Event
Malfunction
·BIO-RAD LABORATORIES, INC.·Product code KSF·May 18, 2023
LIFESHIELD
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·May 14, 2026
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017
HEATER-COOLER SYSTEM 3T
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWC·July 31, 2017
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Malfunction
·AIZU OLYMPUS CO., LTD.·Product code FDT·November 4, 2022