What is being recalled and why?

Abbott Point Of Care i-STAT CG8+, EG7+, and EG6+ cartridges are being recalled because they lack 510(k) premarket clearance for updates to sample types and measurement ranges. This regulatory issue affects units distributed nationwide in the United States.

What should I do if I own or use these cartridges?

Stop using the product immediately. Follow the recall instructions provided by Abbott and consult your healthcare provider for further guidance.

Are there any reported injuries from these cartridges?

No injuries or incidents have been reported to date.

How can I verify if a cartridge is affected?

Check the List Number 03P77-25 and confirm that the cartridge lot is part of the US distribution. Contact Abbott Point Of Care for confirmation.

Will Abbott provide a replacement or refund?

Guaranties for replacement or refund will be provided per Abbott’s recall instructions. Follow the official notification methods.

Where can I get more information about the recall?

Visit the FDA enforcement page for the recall notice and Abbott’s recall communications for guidance.

Should I dispose of affected cartridges?

Follow Abbott’s instructions. Do not discard unless advised.

Who is responsible for evaluating the regulatory status of these cartridges?

Abbott Point Of Care and relevant regulatory authorities oversee clearance status.

Will this recall affect patient test results already generated?

The recall notice does not specify impact on previously generated results. Clinicians should follow institutional protocols.

How long does the recall remediation typically take?

The recall timeline is determined by Abbott in coordination with regulators and may vary by facility.

What identifiers should I look for on cartridges?

List Number 03P77-25 is the primary identifier mentioned in the recall.

HIGHAugust 21, 2025

Abbott i-STAT CG8+, EG7+, EG6+ Cartridges Recalled in 2025 Over Missing 510(k) Clearance

Abbott Point Of Care recalled 547,250 i-STAT CG8+, EG7+, and EG6+ cartridges distributed nationwide in the United States. The recall concerns lack of 510(k) premarket clearance for updated sample types and measurement ranges. Hospitals and clinicians should stop using these cartridges immediately and follow Abbott’s recall instructions.

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

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

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.

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

547,250 units recalled
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

View Original Recall on FDA - Medical Devices

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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 Classification

CategoryHealth & Personal Care › Medical Devices

Product Typei-STAT CG8+, EG7+, and EG6+ cartridges

Product Details

May 9, 2026

BMW

A damaged