3,654 results · 33ms · Sources: EU EUDAMED, US FDA

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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