Alinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
This recall has been terminated (originally issued June 10, 2019).
- Recall Initiated
- June 10, 2019
- Terminated
- June 14, 2023
- Recall Number
- Z-2363-2019
- Quantity
- 1763 units
- Official Source
- View on FDA website ↗
Reason for Recall
Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
All serial numbers
Root Cause
Software in the Use Environment
Action Taken
Abbott sent an Urgent Product Correction Notice by letter dated 06/10/2019. The letter identified the affected product, problem and actions to be taken. Abbott has identified an issue with all onmarket versions of Alinity ciseries Software where reuse of reaction vessels (RVs) may occur after a system Stop. This issue only occurs if the system is transitioned from Processing to Stopped to Idle and has the potential to cause incorrect results.The letter provided a mitigation strategy for the consignee to use until the updated software is available. For questions U.S. Customers contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.