Abbott Alinity ci System Control Module Recalled for Quality Control Failures
Abbott is recalling Alinity ci System Control Modules because quality control results were not properly evaluated for failures.
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: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where specific injuries have not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Abbott GmbH & Co. KG is recalling the Alinity ci series System Control Module (SCM), part number LN 3R70-01, and Alinity ci series software versions 3.1.1 and below. The recall involves 3,166 units distributed worldwide, including the United States and numerous international countries.
The recall was initiated because quality control results were not properly evaluated for quality control failures. This defect could potentially affect the reliability of the system's performance.
Healthcare facilities and users should contact Abbott for instructions on how to address the affected units. The recall covers all serial numbers of the System Control Module.
The recalled product
- Product
- Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
- Manufacturer
- Abbott Gmbh & Co. KG
- Hazard
- Affected units
- 3,166
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers of System Control Module
Distribution
Distributed nationwide across the United States.
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