HIGH

Abbott Point Of Care i-STAT EG7+ Cartridges Recalled Over 6.1 Million Units in 2025

Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges distributed nationwide in the United States. The recall centers on lack of 510(k) clearance for updated sample types and measurement ranges. Healthcare providers and patients should stop using the cartridges immediately and follow Abbott’s recall instructions for next steps.

Quick Facts at a Glance

Recall Date
August 21, 2025
Hazard Level
HIGH
Brand
Abbott Point Of Care
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott Point Of Care Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

i-STAT CG8+, EG7+, and EG6+ cartridges are used with Abbott’s i-STAT portable blood analyzer to provide rapid lab results in clinical settings.

Why This Is Dangerous

The updated sample type and measurement ranges were not cleared by FDA premarket review, potentially affecting test results.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Healthcare providers must identify affected lots, stop use, and follow recall procedures to avoid incorrect test readings.

Practical Guidance

How to identify if yours is affected

  1. Confirm the product is an i-STAT CG8+, EG7+, or EG6+ cartridge with List Number 03P76-25.
  2. Check all packaging for List Number 03P76-25 and any listed lot numbers.
  3. Review Abbott recall notifications for specific instructions on handling and returns.

Where to find product info

On the cartridge packaging, on Abbott recall notices, and the FDA recall page linked to the 03P76-25 listing.

What timeline to expect

4-8 weeks for refunds or replacements after eligibility is confirmed.

If the manufacturer is unresponsive

  • File a formal complaint with the FDA recall process if the company is slow to respond.
  • Consult your healthcare provider for interim guidance and documentation of the issue.

How to prevent similar issues

  • Always verify 510(k) clearance status for updated medical devices.
  • Use only cleared cartridges with your analyzers.
  • Monitor recall notices from FDA and the manufacturer.
  • Document all purchases and keep copies of recall communications.

Documentation advice

Keep the recall notice, purchase receipts, packaging photos, and any correspondence with the manufacturer and healthcare providers.

Product Details

Model numbers: List Number 03P76-25. All lot numbers. Sold: US nationwide distribution. Sold from: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 6,115,950 units recalled
  • List Number 03P76-25
  • All lot numbers affected
  • Distributed nationwide in the U.S.
  • Stop use immediately
  • Follow Abbott recall instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
03P76-25
Affected States
ALL
Report Date
September 24, 2025
Recall Status
ACTIVE

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