Julai 2021 : Product Correction FA26JUL2021 . Urgent ‐ Immediate Action Required : Alinity ci‐series System Control Module (SCM) - Potential performance issues for the Alinity ci‐series Software version 3.2.3 and earlier

Product Correction FA26JUL2021 . Urgent ‐ Immediate Action Required : Alinity ci‐series System Control Module (SCM) - Potential performance issues for the Alinity ci‐series Software version 3.2.3 and earlier

 

Affected Medical Device : 

Alinity ci‐series
System Control Module (SCM)

 

MDA Reference Number : MDA/FCA/2021-P114

 

MDA Registration Number : IVDA3247720-46201

 

Decription : Abbott has identified three potential performance issues for the Alinity ci‐series Software version 3.2.3 and earlier. Abbott is releasing Alinity ci‐series Software version 3.3.0 to correct these issues (see details in Appendix A).

 

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.