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, PREGNANT, PETS
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
- Laboratory Cartridge
- Model numbers
- List Number 03P85-25
- Colors
- Unknown
- Sizes
- Unknown
- 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 CG4+ cartridge to reflect updated sample type for lactate 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 CG4+ cartridge is used with blood gas and lactate testing within point-of-care systems, enabling rapid clinical results.
Why This Is Dangerous
The lack of 510(k) clearance for updated sample type and measurement ranges could lead to misinterpretation of test results.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate stop-use is required to prevent potential misinterpretation of critical test results in point-of-care settings.
Practical Guidance
How to identify if yours is affected
- Locate List Number 03P85-25 on packaging or documentation
- Verify lot numbers for affected units (all lots)
- Cross-check with internal inventory records
Where to find product info
Refer to FDA recall Z-2582-2025 page and Abbott communications; contact manufacturer for confirmation
What timeline to expect
Remedy timelines are determined by Abbott and disclosed in recall communications; expect updates
If the manufacturer is unresponsive
- Document all outreach attempts to Abbott
- Contact the FDA or local health authority if manufacturer unresponsive
- Consider legal counsel for breach of medical device clearance if applicable
How to prevent similar issues
- Verify 510(k) clearance and updated parameters before accepting new lots
- Keep abreast of FDA recall notices for medical devices
- Train staff to quarantine recalled lots upon receipt
- Maintain robust lot-tracking and supplier communications
Documentation advice
Retain recall notifications, packaging, receipts, and correspondence for records
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Product Details
Model numbers: List Number 03P85-25. All lot numbers. Distribution: US nationwide. Quantity: 9,067,050 units. Remedy: Stop use and follow recall instructions. Manufacturer contact: Abbott Point Of Care Inc.
Reported Incidents
No incidents or injuries are reported in the provided data.
Key Facts
- List Number 03P85-25
- Lack of 510(k) clearance for updated lactate sample type and pH/PO2 ranges
- US nationwide distribution
- High hazard level
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Safety Guide
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