Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE 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 sam Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE 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 sam
Brand
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Lot Codes / Batch Numbers
List Number: 03R70-01 ALL LOTS
Products Sold
List Number: 03R70-01 ALL LOTS
Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany is recalling The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. due to All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).
Recommended Action
Per FDA guidance
On May 21, 2019, the firm sent Product Correction Urgent - Immediate Action Required letters to all of their consignees which advised them of the problem and provided them with instructions for preforming additional testing. US customers were sent this letter and an attached Customer Reply Immediate Action Required form vis FedEx priority overnight express. Abbott service personnel will follow-up to install new software.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026