Abbott i-STAT EG7+ Cartridge Recall: Lack of Premarket Clearance

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Recalling firmAbbott Point Of Care Inc.400 College Rd E, N/A · Princeton, NJ 08540-6607

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Abbott is recalling i-STAT EG7+ cartridges because they lack proper premarket clearance for updated sample types and measurement ranges. This does not pose a safety risk to users.

Why it’s dangerous

The cartridges lack 51:0(k) premarket clearance for updated sample types and measurement ranges. This means the product may not meet regulatory standards for potassium and ionized calcium tests, but it does not cause harm during normal use.

Who’s affected

Healthcare professionals using i-STAT EG7+ cartridges for blood tests. The risk is minimal as the product is safe for use.

How to tell if you have this one

Check for the i-STAT EG7+ cartridge with list number 03P76-25. All lot numbers are affected.

Brand
Abbott
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the i-STAT EG7+ cartridge with list number 03P76-25 and all lot numbers.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

No, the product is safe for use. The recall is for regulatory compliance, not safety risks.

Do I need to stop using the cartridge?

No action is needed. The product is safe for use.

What should I do if I have the cartridge?

No action is required as the product is safe for use.

Take action

Contact Abbott

We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2584-2025 — Abbott Abbott

Hello,

I own a Abbott that is covered by recall Z-2584-2025 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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Where this comes from

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.

Official source: FDA Recall #Z-2584-2025 (August 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2584-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Abbott Point Of Care Inc. recalls i-STAT EG7+ cartridge. List Number: 03P76-25.

Lower-risk recall