Abbott Alinity Reaction Vessels Recalled for Potential Contaminant
Abbott Laboratories recalled 70 cases of Alinity Reaction Vessels due to potential contamination that could affect optical performance. Units were distributed across multiple U.S. states.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III recall for potential contamination affecting medical device optical performance. No illnesses, injuries, or confirmed contamination have been reported, and the hazard is theoretical rather than confirmed, placing this at the Moderate severity level per the rubric.
Plain-English summary
Abbott Laboratories is recalling 70 cases of Alinity Reaction Vessels, model REF 06P1401, used with Alinity i Systems and ARCHITECT Reaction Vessels. The reaction vessels may contain a potential contaminant that could affect their optical performance.
The affected products were distributed throughout the United States in Illinois, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New York, Oklahoma, South Carolina, Texas, and West Virginia. Specific lot numbers have been identified as part of this recall.
Healthcare facilities and consumers should contact Abbott Laboratories for instructions regarding replacement or proper handling of affected units.
The recalled product
- Product
- Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
- Manufacturer
- Abbott Laboratories
- Affected units
- 70
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)
- UDI-DI/Lots: 00380740129026/000586790 and 000586879
Distribution
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