Abbott GmBH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
Brand
Abbott GmBH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Lot Codes / Batch Numbers
REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03
Products Sold
REF # 07P7220 Lot # 54454UQ03 and REF # 07P7230 Lot # 54449UQ03
Abbott GmBH & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany is recalling Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince due to Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 10/23/19, a Product Recall letter was issued to all worldwide Alinity c Carbon Dioxide Reagent customers who received the in-date lots. US customers were sent this information via FedEx priority overnight. Customers are asked to immediately discontinue use and destroy product from LN 07P7230 lot 54449UQ03. For LN 07P7220 lot 54454UQ03, the product may continue to be used but 2 levels of CO2 controls must be run every hour until the new material is received. If you or any of the health care providers you serve have any questions regarding this information, US Customers can contact Customer Service at 1-877-4ABBOTT (available 24 hours a day, 7 days a week). Customers outside the US , please contact your local area Customer Service.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026