Ogos 2021 : Field Safety Notice BDB-21-4224-FA - OneFlow Set Up Beads : Incorrect MFI target ranges for APC-H7 are listed on the Monthly and Daily Target Range Cards for the specific lots of BD OneFlow™ Setup Beads
Field Safety Notice BDB-21-4224-FA - OneFlow Set Up Beads : Incorrect MFI target ranges for APC-H7 are listed on the Monthly and Daily Target Range Cards for the specific lots of BD OneFlow™ Setup Beads
Affected Medical Device : BD OneFlow™Setup Beads
MDA Reference Number : MDA/FCA/2021-P130
MDA Registration Number :
IVDC99251235918
IVDC13068191918
IVDC73928277518
IVDC64646261418
IVDC49082309918
Decription : the incorrect MFI target ranges for APC-H7 are listed on the Monthly and Daily Target Range Cards for the specific lots of BD OneFlow™ Setup Beads listed in the table above.
Local Establishment Contact Detail :
Patricia Netto
Regulatory Affairs , Senior Executive
No 6, Changkat Semantan, Damansara Heights,Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 50490
t: 603.20938788
Email : [email protected]
