20 results
·
61ms
·
Sources: EU EUDAMED, US FDA
COBE SPECTRA
FDA Adverse Event
Death
·GAMBRO BCT, INC.·Product code GKT·August 16, 2000
TRIMA AUTOMATED BLOOD COMPONENT COLLECTION
FDA Adverse Event
Other
·GAMBRO BCT, INC.·Product code LKN·August 8, 2000
SPECTRA APHERESIS SYSTEM
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code LKN·October 26, 2008
TRIMA EXCEL LRS PLAT, PLAS, RBC BLOOD TUBING SET
FDA Adverse Event
Death
·GAMBRO BCT, INC.·Product code LKN·November 15, 2007
TRIMA
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code GKT·December 27, 2007
SPECTRA
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code LKN·February 5, 2003
COBE SPECTRA THERAPEUTIC PLASMA EXCHANGE SET
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code LKN·March 20, 2007
TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
FDA Adverse Event
Other
·GAMBRO BCT, INC.·Product code LKN·February 16, 2007
COBE SPECTRA APHERESIS TUBING SET
FDA Adverse Event
Other
·GAMBRO BCT, INC.·Product code LKN·December 9, 2005
COBE DISPOSABLE AUTO PBSC SET
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code KSR·October 11, 2005
COBE SPECTRA
FDA Adverse Event
Other
·GAMBRO BCT, INC.·Product code LKN·April 27, 2006
COBE SPECTRA APHERESIS SYSTEM
FDA Adverse Event
Death
·GAMBRO BCT, INC·Product code LKN·June 13, 2006
GAMBRO BCT BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code LKN·March 12, 2001
SPECTRA APHERESIS SYSTEM
FDA Adverse Event
Death
·GAMBRO BCT, INC.·Product code LKN·August 3, 2007
TRIMA ACCEL ENHANCED PLT, PLS, RBC SET
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code GKT·December 1, 2011
COBE SPECTRA LRS TURBO VERSION 7.0
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code GKT·October 5, 2004
COBE SPECTRA APHERESIS SYSTEM TUBING SET
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·Product code LKN·June 7, 2007
1722028-2013-01307
FDA Adverse Event
Malfunction
·GAMBRO BCT, INC.·July 29, 2013
SPECTRA OPTIA APHERESIS SYSTEM
FDA Adverse Event
GAMBRO BCT, INC.·Product code LKN·March 13, 2008
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
FDA Recall
Terminated
·Gambro BCT, Inc.·Product code LKN·September 18, 2007