10,000 results · 85ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

IMMUNOCHEMISTRY ANALYZER -JJE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·September 18, 2009

SYNCHRON VANCOMYCIN REAGENT

FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011

ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JIS·March 5, 2012

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code DHA·June 2, 2011

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·June 6, 2011

ADVIA CENTAUR XP

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·March 25, 2016

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·June 6, 2011

ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·September 18, 2013

ACCESS® VITAMIN B12

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code CDD·February 1, 2012

ARCHITECT C4000 ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·March 10, 2019

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER, INC.·Product code MMI·May 20, 2011

ADVIA CENTAUR RUBELLA G (RUB G) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LFX·March 26, 2013

ACCESS® TOXO IGG

FDA Adverse Event
BECKMAN COULTER, INC.·Product code LGD·February 17, 2012

CALCIUM

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES (IRVING IA/CC)·Product code CJY·September 1, 2020

ARCHITECT C8000 ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·September 16, 2018

DIMENSION VISTA 1500

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·August 21, 2019

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·November 21, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021

VIDAS® ANALYZER

FDA Adverse Event
Malfunction ·BIOMERIEUX ITALIA S.P.A.·Product code JJE·October 27, 2021