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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abbott Point Of Care
- Product type
- Diagnostic Cartridge
- Model numbers
- 03P76-25
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 21, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
- List Number 03P76-25
- All lot numbers affected
- Distributed nationwide in the U.S.
- Stop use immediately
- Follow Abbott recall instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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