Abbott recalls Alinity c Carbon Dioxide Reagent Kits produced in Prince Edward Island, Canada, due to potential for incorrect test results from absorbed atmospheric CO2.
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.
Abbott is recalling Alinity c Carbon Dioxide Reagent Kits made in Prince Edward Island, Canada. These kits can give incorrect test results because atmospheric CO2 gets absorbed into the reagent, which may affect patient results.
Atmospheric carbon dioxide can be absorbed into the reagent kit, especially when the reagent carousel rotates more or the cartridge volume is smaller. This absorption can cause shifts in quality control tests, potentially leading to incorrect patient results.
Users of the Alinity c Carbon Dioxide Reagent Kit who purchased it from Abbott's Canadian distribution in Prince Edward Island. Patients using these kits for medical testing are most at risk of inaccurate results.
Check for the reagent kit with reference numbers REF # 07P7220 Lot # 54454UQ03 or REF # 07P7230 Lot # 54449UQ03. These kits were produced in Prince Edward Island, Canada.
Look for reference numbers REF # 07P7220 Lot # 54454UQ03 or REF # 07P7230 Lot # 54449UQ03 on the kit packaging.
Abbott internal studies found that atmospheric carbon dioxide can be absorbed into the reagent, causing potential incorrect test results, especially with increased carousel rotation or smaller cartridge volumes.
Check for reference numbers REF # 07P7220 Lot # 54454UQ03 or REF # 07P7230 Lot # 54449UQ03 on the kit packaging.
The recall record does not specify a remedy, so contact Abbott directly for guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0575-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0575-2020 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
