Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50

 

 

Affected Medical Device : 

ARCHITECT i1000SR
ARCHITECT i2000SR
ARCHITECT i2000
ARCHITECT c4000
ARCHITECT c8000
ARCHITECT c16000

 

MDA Reference Number : MDA/FCA/2021-P139

 

MDA Registration Number : 

IVDA3676020-43793
IVDA11021198618
IVDA6584220-49724

 

Decription : Abbott has identified three potential performance issues for the ARCHITECT Software version9.41 and earlier.1.

 

Local Establishment Contact Detail :

Farah Syuhaidah Ahmad Jahiddin
RA & QA Executive
Core Diagnostics
Abbott Laboratories (M) Sdn Bhd
22, Jln Pemaju U1/15,Seksyen U1,Hicom-Glenmarie Ind. Park,40150 Shah Alam, Selangor,Malaysia
+603-5566 3473

Email : farahsyuhaidah.ahmadjahiddin@abbott.com

 

 A copy of FSN.