Abbott Alinity i Accessory Kit Recalled for Potential Sensor Cracks
Abbott is recalling Alinity i accessory kits because environmental stress may cause cracks in the bulk solution level sensor.
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 describes a potential reliability issue (cracks) without reporting specific injuries, hospitalizations, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abbott Gmbh & Co. KG is recalling 3,271 units of the Accessory kit, Alinity i containing 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 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. The recall covers List Number 03R66 03 and all serial numbers.
Consumers and healthcare facilities should stop using the affected accessory kits and contact Abbott for further instructions on replacement or return.
The recalled product
- Product
- Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 3,271
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 03R66 03
- 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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- HighAbbott Alinity ci-series Software Recalled for Performance Issues
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Same hazard · reliability issue
See all →- ModerateAbbott Alinity ci Level Sensor Recalled for Potential Cracking
FDA (Devices) · 2019-12-04
- ModerateAbbott Alinity ci Level Sensor Bulk Solution Recalled for Reliability Issues
FDA (Devices) · 2019-12-04