Abbott Alinity ci-series System Control Module Software Recall
Abbott is recalling Alinity ci-series System Control Module software version 2.5.1 due to potential performance issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites 'potential performance issues' without reporting specific injuries, illnesses, or hospitalizations, aligning with the criteria for moderate severity.
Plain-English summary
Abbott Gmbh & Co. KG is recalling the Alinity ci-series System Control Module software version 2.5.1. The recall involves specific hardware components, including the Level Sensor, Bulk Solution, and Accessory Kits for the Alinity i and Alinity c processing modules.
The recall is being issued due to potential performance issues associated with the software version. The Alinity i and Alinity c modules are fully automated analyzers used for immunoassay and chemistry testing, respectively. The affected units were distributed across 19 U.S. states, Puerto Rico, and numerous international locations.
Healthcare facilities and users of the Alinity ci-series systems should contact Abbott for further instructions regarding the recall and any necessary corrective actions.
The recalled product
- Product
- Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The
- Manufacturer
- Abbott Gmbh & Co. KG
- Hazard
- Affected units
- 1,557
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 (10)
- Alinity ci series System Control Module
- LN 3R70 01 Level Sensor
- Bulk Solution
- LN 04S68 01 Accessory kit
- Alinity i
- LN 03R66 01
- LN 03R66 02 Accessory kit
- Alinity c
- LN 03R69 01
- LN03R69 02
Distribution
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