Z-2363-2019Class II

Alinity ci -series System ControlModule, Part Number 03R70 01

Name: Z-2363-2019 Alinity ci -series System ControlModule, Part Number 03R70 01
Creator: Abbott Gmbh & Co. KG
Published: 2019-06-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-06-10 / Terminated / root cause: software

FDA source

Abbott Gmbh & Co. KG began a recall of 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... on 2019-06-10. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2363-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Posted: 2019-08-24
Terminated: 2023-06-14
Recalling firm: Abbott Medical
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 1763 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2363-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2363-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-04	2019-08-23

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)