145 results
·
30ms
·
Sources: EU EUDAMED, US FDA
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 24, 2011
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 23, 2011
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LTJ·March 23, 2011
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 26, 2011
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code LTJ·March 30, 2011
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 3, 2012
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·March 13, 2012
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·March 13, 2012
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·March 13, 2012
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·March 13, 2012
ICON II HCG (URINE)
FDA Adverse Event
Malfunction
·HYBRITECH, INC.·Product code JHJ·September 30, 1996
CONCISE MONO TEST
FDA Adverse Event
Injury
·HYBRITECH, INC.·Product code KTN·May 18, 1993
ICON GROUP B STREP ASSAY
FDA Adverse Event
Malfunction
·HYBRITECH INC.·Product code GTZ·December 4, 1996
TANDEM CEA ERA
FDA Adverse Event
Malfunction
·HYBRITECH, INC.·Product code DHX·October 23, 1996
TANDEM-E PSA (FOR USE WITH PHOTON ERA)
FDA Adverse Event
Malfunction
·HYBRITECH INC.·Product code LTJ·October 23, 1996
ICON II HCG (URINE)
FDA Adverse Event
Malfunction
·HYBRITECH, INC.·Product code JHJ·November 1, 1996
ICON II HCG (SERUM)
FDA Adverse Event
Malfunction
·HYBRITECH, INC.·Product code JHJ·December 4, 1996
ICON IMMUNOCONCENTRATION ASSAY FOR GROUP B STREP
FDA Adverse Event
Injury
·HYBRITECH INC.·Product code GTZ·October 11, 1996
ICON II HCG (URINE)
FDA Adverse Event
Malfunction
·HYBRITECH, INC.·Product code JHI·December 18, 1996
TANDAM CEA ERA
FDA Adverse Event
Malfunction
·HYBRITECH, INC.·Product code DHX·February 12, 1997