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 : Patricia.Netto@bd.com

 

 A copy of FSN.