18 results · 54ms · Sources: EU EUDAMED, US FDA

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PROBECHEK PATHVYSION HER-2/NEU NORMAL CONTROL

FDA Adverse Event
Malfunction ·ABBOTT MOLECULAR, INC.·Product code KIR·September 1, 2009

VITROS CHEMISTRY PRODUCTS CA SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CJY·December 6, 2018

VITROS CHEMISTRY PRODUCTS CA SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CJY·December 6, 2018

VITROS CHEMISTRY PRODUCTS CA SLIDES

FDA Adverse Event
Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code CJY·December 6, 2018

BD¿ SHARPS COLLECTOR 9 GAL

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·January 17, 2019

VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JGS·December 20, 2016

Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 12, 2025

Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003

SHARPS COLL SLIDE CLOSE 19GAL PHARM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·September 9, 2021

BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·August 1, 2023

SHARPS COLL 1QT RED

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·April 2, 2021

BD¿ EXTRA LARGE SHARPS COLLECTOR SLIDE TOP, 19 GAL, RED

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·September 7, 2023

SHARPS COLL 17GAL RED

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·June 25, 2020

SHARPS COLL CHEMO 17GAL YELLOW

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code MMK·June 24, 2020

SHARPS COLL 19GAL RED

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMI·November 13, 2020

BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·January 29, 2022

DEXCOM SEVEN PLUS CGMS

FDA Adverse Event
Injury ·DEXCOM·Product code MDS·November 20, 2011