FSCA Notifications - 006 ASW 22-01 Atellica CH 930 Analyzer : Issues with setting Open Channel Assay parameters.

 

 

Affected Medical Device : Atellica CH 930 Analyzer

 

MDA Reference Number : MDA/FCA/2021-P171

 

MDA Registration Number : IVD34641418218A

 

Description :

1 - TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Values - If TDef parameters have been edited for an Open Channel Assay under the CH Test Definition screen, the next time an Open Channel configuration screen is edited, it may overwrite the previously edited Open Channel TDef parameters on the CH Test Definition screen with default values.
2 - On Board Stability (OBS) Not Updating with Manual Changes - When the customer manually changes the onboard stability (OBS) for reagent packs for open channel assays, the operator will only see a change for Reagent 1-Well-1 with no change to R1-Well-2, R2-Well-1, and R2-Well-2. The system may continue to use the reagent past its OBS date leading to potential erroneous patient sample results.

 

Local Establishment Contact Detail :

Wilson Ng
Siemens Healthcare Sdn. Bhd.
Quality & Technology
HC APC ASN MAS QT
Level 16-1 & 16-2, CP Tower
No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya,Selangor Darul Ehsan, Malaysia
Tel: +60 3 79525555

 

Email : weil-shern.ng@siemens-healthineer>

 

 A copy of FSN.