Abbott recalls i-STAT CG8+ potassium cartridges that may give inaccurate potassium results, especially with low or high potassium samples. Affected units include specific lot numbers and box numbers.
Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be generated. When testing with samples with a high concentration of potassium, decreased potassium results may be generated
Abbott is recalling i-STAT CG8+ potassium test cartridges that can produce inaccurate potassium results. This may lead to incorrect medical decisions if used for blood testing. The issue affects specific lot numbers and box numbers.
The cartridges may generate elevated potassium results when testing samples with low potassium concentrations or decreased results when testing samples with high potassium concentrations. This inaccuracy could lead to incorrect medical decisions.
Healthcare professionals using these cartridges for potassium testing are most at risk. Patients relying on accurate potassium results from these tests could be affected if the results are inaccurate.
Check for lot number L18059 and box numbers 0221-0233 on the cartridge packaging. The list number/UDI# starts with 03P88-25.
Look for lot number L18059 on the cartridge packaging.
Confirm box numbers 0221, 0222, 0223, 0224, 0231, 0232, or 0233.
The cartridges may generate inaccurate potassium results, especially with samples that have low or high potassium concentrations.
Check the lot number and box numbers on the packaging. If they match the affected units, contact Abbott for guidance.
The risk is low as the issue only affects test accuracy, not physical safety.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0615-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0615-2019 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.
