Abbott recalls i-STAT CG8+ cartridges due to lack of updated 510(k) clearance for potassium and calcium measurements. Affected units may not provide accurate test results. Contact Abbott for details.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Abbott is recalling i-STAT CG8+ cartridges because they lack updated 510(k) clearance for accurate potassium and calcium measurements. This could lead to incorrect test results if used without the proper clearance.
The cartridges lack updated 510(k) clearance for potassium and calcium measurements, which could lead to inaccurate test results. This may affect blood test accuracy for critical health indicators.
Healthcare professionals using i-STAT CG8+ cartridges for blood tests may be affected. Those who rely on accurate potassium and calcium measurements are at higher risk.
Check for i-STAT CG8+ cartridges with list number 03P88-25. All lot numbers are affected. The product is sold under Abbott Point Of Care Inc.
Look for the list number 03P88-25 on the cartridge packaging.
The i-STAT CG8+ cartridges lack updated 510(k) clearance for accurate potassium and calcium measurements.
No, but you should check the list number to confirm if your cartridge is affected.
Contact Abbott directly for guidance on next steps.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2583-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2583-2025 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.
