3,654 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CHROMI(TM) OXA
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JXA·March 28, 2016
CHROMID(TM) OXA
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JXA·March 28, 2016
CHROMID(TM) OXA
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JXA·March 28, 2016
KIT BD MAX CHECK-POINTS CPO IVD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code POC·February 23, 2023
BD MAX¿ CHECK-POINTS (CPO)
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·September 16, 2025
VITEK® 2 AST -P654 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·November 30, 2018
FILMARRAY® TORCH MODULE
FDA Adverse Event
Malfunction
·BIOFIRE DIAGNOSTICS, LLC·Product code NSU·August 22, 2025
VITEK® 2 AST -P654 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·November 30, 2018
BD MAX¿ CHECK-POINTS (CPO)
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·September 16, 2025
VITEK® 2 AST -P654 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·November 30, 2018
VITEK® 2 SYSTEMS SOFTWARE VERSION 8.01
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·November 16, 2018
VITEK® 2 AST-P631 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·April 19, 2017
CHROMID CARBA SMART AGAR
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JSI·May 2, 2016
OXA1SMXUIDC
FDA UDI
UTAK LABORATORIES, INC.·B800OXA1SMXUIDC0·OXA1SMXUIDC
OXA2SMXUIDC
FDA UDI
UTAK LABORATORIES, INC.·B800OXA2SMXUIDC0·OXA2SMXUIDC
OXACALSMXUIDC
FDA UDI
UTAK LABORATORIES, INC.·B800OXACALSMXUIDC0·OXACALSMXUIDC
VITEK® 2 AST -P654 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·November 30, 2018
RAPIDEC CARBA NP
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code PTJ·November 25, 2020
BD MAX¿ CHECK-POINTS (CPO)
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·September 16, 2025
API® RAPIDEC® CARBA NP
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code PTJ·February 5, 2019