Field Safety Notification FA-21073 on AU/DxC AU Uric Acid : Failed to meet the conjugated bilirubin interference specification for the serum application as defined in IFU

 

 

Affected Medical Device : AU/DxC AU Uric Acid

 

MDA Reference Number : MDA/FCA/2021-P178-2

 

MDA Registration Number : IVDB54451262818

 

Description :

During internal interference testing completed as part of the In Vitro Diagnostic Regulation (IVDR) remediation project, Beckman has determined that Uric Acid failed to meet the conjuget bilirubin interference specification for he serum application as defined in the IFU: Interference less than 10% up to 20 mg/dL or 342 umol/L conjugated bilirubin.

 

Local Establishment Contact Detail :

Nur Aishah
REGULATORY AFFAIRS SPECIALIST
O: +03-7772 8256 
www.beckmancoulter.com | 
Beckman Coulter Malaysia
18, Jalan Tandang 51/205a, Pjs 51, 46050 Petaling Jaya, Selangor, Malaysia

 

Email : nbintiabdaziz@beckman.com

 

 A copy of FSN.