6 results
·
46ms
·
Sources: EU EUDAMED, US FDA
CLEARVIEW SIMPLIFY D-DIMER
FDA Adverse Event
Death
·AGEN BIOMEDICAL LTD.·Product code GHH·April 24, 2007
CLEARVIEW SIMPLIFY D-DIMER
FDA Adverse Event
Malfunction
·AGEN BIOMEDICAL LTD.·Product code GHH·February 20, 2007
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium azide 10 plastic pipettes Wampole Laboratories Inverness Medical Professional diagnostics group Manufactured by Agen Biomedical Ltd, Brisbane, QLD Australia.
FDA Recall
Terminated
·Inverness Medical Professional Diagnostics·Product code GHH·February 15, 2007
CMC Medical Devices & Drugs SL
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