Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- 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
- Beckman Coulter
- Product type
- Immunoassay Analyzer
- Model numbers
- A71460, A71461, A30260
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed 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
The Beckman Coulter UniCel Dxl 600 is an immunoassay analyzer used in healthcare settings to process patient samples for various tests, including cardiac markers like troponin. These analyzers are critical for delivering timely and accurate test results to healthcare professionals.
Why This Is Dangerous
The potential communication issue may cause the device to fail to restart, rendering it unable to process samples. This issue can disrupt clinical workflows and delay essential patient care.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall significantly impacts healthcare facilities relying on the UniCel Dxl 600 for patient testing, leading to potential delays in diagnosis and treatment.
Practical Guidance
How to identify if yours is affected
- Check the model number and part numbers against the recalled list: A71460, A71461, A30260.
- Verify if the analyzer has experienced issues restarting after shutdown.
- Consult the manufacturer or your healthcare provider for further information.
Where to find product info
Model numbers and part numbers can usually be found on the device's identification label or user manual.
What timeline to expect
Expect a response from Beckman Coulter regarding your inquiry within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Beckman Coulter via phone or email.
- Document your communication attempts.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Look for devices with reliable restart features and strong manufacturer support.
- Check for recalls before purchasing laboratory equipment.
- Ensure that devices meet current safety and performance standards.
Documentation advice
Keep records of your purchase, any communications with Beckman Coulter, and photographs of the device for your records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled models are Beckman Coulter UniCel Dxl 600 with part numbers A71460, A71461, and A30260. These analyzers were distributed globally, including the US and countries such as Canada, Germany, and Australia.
Key Facts
- Global distribution including US and Europe
- Immediate action required to stop using devices
- No reported injuries or deaths
- Contact manufacturer for guidance
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.