[pending] Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Pending LLM rewrite. Source: FDA_DEVICE Z-0961-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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.
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