Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity ci-series System Control Module [List Number: 03R70-01; All Serial Number].
The manufacturer has identified potential performance issues for the Alinity ci-series Software version 3.1.2 and earlier. The manufacturer is releasing Alinity ci-series Software version 3.2.0 to correct these issues.
- Issue 1: In a unique scenario, deleting a user-defined dilution protocol, on a clinical chemistry photometric assay, can cause improper dilutions to be performed when running another user-defined protocol for that assay.
- Issue 2: Pipettors diagnostic procedure 4102 Sample Pipettor Calibration (c-series) can miss the sample positioner calibration targets and pass the calibration with incorrect calibration values.
- Issue 3: Cautions associated with biological risks, chemical hazards, and moving parts are not listed in Fluidics-Wash diagnostic procedure 1250 Vacuum Diagnostic (i-series).
The manufacturer is releasing Alinity ci-series Software version 3.2.0 to correct the affected issues. Software version 3.2.0 also includes the fix for the Quality Control functionality issues. Affected users should follow the necessary actions required until mandatory upgrade of the affected device to software version 3.2.0 is installed. Affected users are instructed to do the following actions:
- Issue 1: If an assay with a second and third user-defined dilution protocol is configured, and the operator removes the second dilution, causing the previous dilution 3 to be displayed as dilution 2 upon saving, the user performs the following steps to ensure proper dilution performance:
- Perform Archive the results and Archive the Calibrations.
- Perform Uninstall assay files.
- For Abbott assays, perform Install assay files to reinstall the assay file. For user-defined assays, perform Create user-defined assay (c-series photometric) to recreate the user-defined assay.
- Reconfigure user-defined dilution protocols as desired.
- Perform assay calibrations and controls for the assay.
- Issue 2: After the 4102 Sample Pipettor Calibration (c-series) procedure is completed, perform Pipettors diagnostic procedure 4109 Probe Alignment Test (c-series) to visually check the alignment of the sample pipettor. If the sample pipettor misses the sample positioner target during the visual check, user should contact the local supplier.
- Issue 3: When performing 1250 Vacuum Diagnostic (i-series), the procedure key setting is "Required on". User refers to the caution statements listed in the Alinity ci-series Operations Manual, Section 9: Service, maintenance, and diagnostics, Use a procedure Key to perform a procedure when performing this procedure.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 October 2020