Quick Facts at a Glance
- Recall Date
- November 7, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- 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
- Beckman Coulter
- Product type
- Immunoassay Reaction Vessels
- Model numbers
- UDI-DI: 15099590180249, Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003 +1 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 7, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Access 2 Reaction Vessels are disposable plastic tubes used in medical labs to process patient samples and perform quality control tests. They are crucial for accurate testing in immunoassay systems.
Why This Is Dangerous
Manufacturing deformities in the Reaction Vessels can lead to errors in laboratory instruments, affecting the accuracy and timeliness of patient results.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause delays in patient testing and results, which could impact patient care and treatment decisions.
Practical Guidance
How to identify if yours is affected
- Check the catalog number (81901) on the product.
- If your product matches, it is affected by the recall.
Where to find product info
The catalog number and lot numbers are usually printed on the packaging or label of the Reaction Vessels.
What timeline to expect
Expect a processing time of 4-6 weeks for any refunds or replacements once you follow the recall instructions.
If the manufacturer is unresponsive
- Contact Beckman Coulter again to follow up on your request.
- Document all correspondence for your records.
- Consider filing a complaint with the FDA if you do not receive a response.
How to prevent similar issues
- Always check for product recalls before purchasing medical devices.
- Look for FDA approval and compliance certifications on medical products.
- Ensure that medical devices are sourced from reputable suppliers.
Documentation advice
Keep records of your purchase, including receipts and any correspondence regarding the recall.
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Product Details
The recall involves Access 2 Reaction Vessels, Catalog Number 81901. The affected lots include P243943, P243971, P244202, P244344, P244345, P250001, P250002, P250003, P250004, and P250005. The vessels were distributed nationwide in the U.S.
Key Facts
- Recall date: November 7, 2025
- Quantity recalled: 38,225 units
- Affected catalog number: 81901
- Potential for instrument errors
- No reported injuries or deaths
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