Recall Z-2363-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Gmbh & Co. KG
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 m
| Date | Jun 10, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software in the Use Environment |
| Action | 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 Custom |
| Quantity | 1763 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.