Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption
Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.
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 3/5 (High).
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 involves a risk of incorrect patient results due to reagent contamination, which fits the criteria for high-risk products where injury has not yet been reported.
Plain-English summary
Abbott GmbH & Co. KG is recalling Alinity c Carbon Dioxide Reagent Kits produced by Sekisui Diagnostics P.E.I. Inc. The recall involves 105 kits from lot 54449UQ03 and 1,215 kits from lot 54454UQ03. These products were distributed worldwide and across numerous US states and territories, including Puerto Rico.
Internal studies by Abbott determined that atmospheric carbon dioxide (CO2) can be absorbed into the reagent, which may result in incorrect patient test results. This issue was identified through customer complaints and internal testing, which showed that CO2 absorption increases with reagent carousel rotation and reduced reagent volume. The phenomenon is detectable as a shift in quality control (QC) and is predictive of the potential impact on patient results.
Healthcare facilities and laboratories should stop using the affected lots and contact Abbott for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
- Manufacturer
- Abbott GmBH & Co. KG
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)
- REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03
Distribution
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