Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Alinity c Carbon Dioxide Reagent Kit Recalled by Abbott GmBH & Co. KG Due to Abbott internal studies have determined that atmospheric Carbon...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott GmBH & Co. KG directly.
Affected Products
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Quantity: 105 kits (lot 54449UQ03) and 1215 kits (lot 54454UQ03)
Why Was This Recalled?
Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was made aware of this issue from customer complaints. Internal testing demonstrated that the amount of CO2 absorbed is higher with increased reagent carousel rotation and when the volume of reagent in the cartridge is reduced. This phenomenon can be detected as a shift in QC. The shift is predictive in both direction and magnitude of the potential impact to patient results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott GmBH & Co. KG
Abbott GmBH & Co. KG has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report