Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Pending LLM rewrite. Source: FDA_DEVICE Z-0961-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
The recalled product
- Product
- Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
- Manufacturer
- Abbott Laboratories
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
FDA (Devices) · 2026-07-22
- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22