Abbott recalls i-STAT EG6+ cartridges due to lack of 510(k) premarket clearance for updated potassium and calcium measurements. No immediate action needed as this is a regulatory issue, not a safety hazard.
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 EG6+ cartridges because they lack proper regulatory approval for updated potassium and calcium measurements. This does not pose a safety risk to users but requires correction to meet regulatory standards.
The cartridges lack 510(k) premarket clearance for updated sample types and measurement ranges. This means they may not meet regulatory standards for potassium and calcium testing, but does not cause physical harm.
Users of i-STAT EG6+ cartridges for medical testing. Healthcare professionals and labs using these cartridges are most at risk due to regulatory compliance requirements.
Check for i-STAT EG6+ cartridges with List Number 03P77-25. All lot numbers are affected. This recall is for regulatory compliance, not a safety issue.
Verify if your i-STAT EG6+ cartridges have the required 510(k) clearance for potassium and calcium measurements.
No, this recall is for regulatory compliance, not a safety hazard. The cartridges do not pose a risk of injury.
No action is needed. This is a regulatory issue, not a safety hazard.
No action is required. The recall is for regulatory compliance, not safety.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2585-2025 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2585-2025 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.
