Quick Facts at a Glance
- Recall Date
- August 21, 2025
- Hazard Level
- HIGH
- Brand
- Abbott Point Of Care
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- i-STAT CG8+, EG7+, and EG6+ cartridges
- Model numbers
- List Number 03P77-25
- Sold at
- Unknown
- 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
The i-STAT system uses disposable cartridges for point-of-care blood analysis in clinical settings. These cartridges are used with portable analyzers to rapidly measure various analytes and blood gas parameters.
Why This Is Dangerous
The hazard stems from the lack of regulatory clearance for updated cartridge types and measurement ranges. This could lead to regulatory noncompliance and potential uncertainty in diagnostic results.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt use of these cartridges, potentially affecting testing workflows and requiring regulatory coordination.
Practical Guidance
How to identify if yours is affected
- Identify List Number 03P77-25 on cartridge packaging.
- Confirm the cartridge lot numbers in inventory match those included in the recall.
- Consult Abbott Point Of Care for clearance status before reuse.
Where to find product info
Refer to the recall notice and Abbott communications for identification codes beyond List Number 03P77-25.
What timeline to expect
Remediation timelines are set by Abbott and regulators; expect guidance to be issued by the manufacturer.
If the manufacturer is unresponsive
- Escalate to hospital compliance or risk management offices.
- File a formal inquiry with Abbott Point Of Care if responses are slow.
How to prevent similar issues
- Verify regulatory clearance for new cartridge updates before stocking or using.
- Implement supplier communications to capture regulatory status on new lots.
- Document all recall communications and actions taken.
Documentation advice
Record lot numbers, List Number 03P77-25, dates of inventory, communications with Abbott, and internal decisions regarding use or disposal.
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Product Details
Model numbers: List Number 03P77-25. All lot numbers. Distribution: US nationwide. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lack of 510(k) clearance for updates to CG8+, EG7+, EG6+ cartridges
- US nationwide distribution
- Active recall as of 2025-08-21; FDA enforcement notice updated 2025-09-24
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Safety Guide
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