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
- 973100, A71456, A71457, A25288
- 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 800 is a laboratory analyzer used for immunoassay testing, commonly utilized in healthcare settings to measure biomarkers such as troponin. These devices are essential for diagnosing conditions like heart attacks, making their reliable operation critical.
Why This Is Dangerous
The reported communication issue can prevent the analyzers from properly restarting, which means they cannot process any patient samples or quality controls. This leads to delays in obtaining important test results, which can adversely affect patient treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare providers relying on these devices for timely results may face operational delays, impacting patient care and treatment timelines.
Practical Guidance
How to identify if yours is affected
- Check the part number on your analyzer to see if it matches 973100, A71456, A71457, or A25288.
- Verify the UDI numbers against those provided in the recall notice.
- Contact Beckman Coulter for further verification if needed.
Where to find product info
The part and UDI numbers can typically be found on the device's identification plate or user manual.
What timeline to expect
Expect a response regarding replacements or refunds within 4-6 weeks after contacting Beckman Coulter.
If the manufacturer is unresponsive
- Follow up with Beckman Coulter if you do not receive a response within a week.
- Consider reaching out to regulatory bodies like the FDA for assistance.
How to prevent similar issues
- Ensure any future medical devices are certified by recognized regulatory agencies.
- Regularly check for updates on device recalls or safety notices from manufacturers.
Documentation advice
Keep a detailed record of all communications related to the recall, including emails and phone call notes.
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Product Details
The recall affects Beckman Coulter UniCel Dxl 800 analyzers with part numbers 973100, A71456, A71457, and A25288. These devices were distributed worldwide, including the U.S. and various countries, from January 2023 to November 2025.
Key Facts
- Recall date: November 26, 2025
- Report date: January 14, 2026
- Total units recalled: 6,457
- Classification: Class II
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