18 results
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54ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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