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 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.

Recall number

Z-2363-2019

Recalling firm

Abbott Gmbh & Co. KG

Product

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.

Status

Terminated

Initiated

2019-06-10

Posted

not on file

Terminated

2023-06-14

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 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.

Quantity

1763 units

Distribution

Worldwide Distribution - US Nationwide

Lot, serial or model codes

All serial numbers

510(k) numbers

not on file

PMA numbers

not on file

Product code

JJE

Firm FEI

3002809144

Firm city

Wiesbaden

Firm state

not on file

Firm country

Germany

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy