Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Alinity ci-series System Control Module (SCM) [List Number: 03R70-01; Serial number: Multiple].
The manufacturer has identified three potential performance issues for the Alinity ci-series Software version 3.2.3 and earlier.
- The first issue is a potential on Alinity c and Alinity i for onboard reagents past their lot expiration date or onboard stability time to be incorrectly displayed on the Reagent Status screen with a status of “OK”. In this scenario, the expired reagent will remain in the carousel for sample processing.
- The second issue is when performing monthly maintenance procedure 5701 Clean ICT Drain Tip on Alinity c incorrectly may potentially cause issues such as damaged connector or leaking connection.
- The third issue is a sample exception with message code 150 “Unable to process test. Previous processing module error” on Alinity c is produced without notifying the operator of a reagent pipettor failure. The processing module transitions into the Pausing state. Tests initiated prior to the sample exception may continue to process without dispense of reagents, potentially leading to incorrect results.
The manufacturer is releasing Alinity ci-series Software version 3.3.0 to correct these three issues and affected users should follow the necessary actions listed on the customer letter.
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 4 Aug 2021