Siemens Healthcare Diagnostics has identified issues with the Atellica CH 930 Analyzer, which are installed with Atellica solution software (SW) versions V1.25.1 and lower when using open channelassays. Siemens Healthineers assays are not impacted. Issue 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. Issue 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. Recall start date: Nov 24, 2021
RecallTracker