Important Safety Alerts

Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity ci-series System Control Module [List Number: 03R70-01; Serial Number: All; only includes Alinity ci-series System Control Modules which are configured with Alinity i Processing Modules].

The manufacturer has identified an issue with all on-market versions of Alinity ci-series software where re-use of reaction vessels (RVs) may occur after a system Stop. The issue only occurs if the system is transitioned from Processing to Stopped to Idle and has the potential to cause incorrect patient results for any Alinity i assay.

According to the manufacturer, the following specific sequence of events are required to experience the issue:

1. The system is processing tests.
2. A processing module 'stop' event occurs. The stop event can be system initiated (for example, due to a hardware failure that places the system in Stopped status) or due to an operator request to Stop the system.
3. The operator requests a Start on the module that stopped. The system performs an initialization to transition to the Idle state.
4. The operator requests a Run to transition the system to Running.

If the prior run ended with a stop while sample or reagent are in the process of being aspirated or dispensed into RVs, there could be sample/reagent in the RVs between the sample dispense and the stat diverter. Up to 4 RVs would be retained in the clean lane and could be used for future tests. If the operator does not perform step 3 (Start), the issue does not occur.

The manufacturer will be releasing Alinity ci-series Software version 2.6.2 to resolve the issue. To mitigate the issue until the software is available, operator should follow the steps below:

1. When system is stopped, go directly to running
2. If the system is in a Stopped state and the operator transitions to an Idle state, the operator must clear all RVs from the process path. Perform process path diagnostic procedure 1520 RV Load and Unload Test to unload and load all RVs from the process path.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 19 June 2019