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
Confirm the product is an i-STAT CG8+, EG7+, or EG6+ cartridge with List Number 03P76-25.
Check all packaging for List Number 03P76-25 and any listed lot numbers.
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.
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