Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 13, 2025 |
| Reported | December 24, 2025 |
| Recalling firm | Abbott Laboratories |
| Country / region | United States TX |
Hazard
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.
Affected products
- Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
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