Abbott Alinity ci Level Sensor Recalled for Potential Cracking
Abbott is recalling Alinity ci Level Sensors, Bulk Solution, because environmental stress may cause cracks that affect reliability.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically corresponds to a Moderate severity score when no specific hospitalizations or serious injuries are reported in the source text.
Plain-English summary
Abbott Gmbh & Co. KG is recalling 8,714 units of the Alinity ci Level Sensor, Bulk Solution. The recall is due to a potential reliability issue where environmental stress on the bulk solution level sensor can cause cracks.
The affected products are identified by List Number 04S68-02 and include all serial numbers. These units were distributed nationwide to 33 U.S. states and Puerto Rico, as well as internationally to numerous countries including Canada, the United Kingdom, and Australia.
This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should contact Abbott for further instructions on how to proceed with the recalled devices.
The recalled product
- Product
- Alinity ci Level Sensor, Bulk Solution
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 8,714
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 (2)
- List Number 04S68-02
- All Serial Numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Abbott Gmbh & Co. KG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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