Quick Facts at a Glance
- Recall Date
- September 19, 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
- DxI 9000 Access Immunoassay Analyzer (P/N C11137), DxC 500i Clinical Analyzer, UDI-DI 15099590732103
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 19, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
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
DxI 9000 and DxC 500i are clinical chemistry instruments used in hospital and reference labs to perform immunoassays and deliver patient results.
Why This Is Dangerous
A software anomaly can misapply manual dilution factors for tests ordered on in-progress samples using the same Sample ID, risking inaccurate results and delayed reporting.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Laboratories may face result inaccuracies and reporting delays that could affect patient care and clinical decision making.
Practical Guidance
How to identify if yours is affected
- Verify device models: DxI 9000 Access Immunoassay Analyzer and DxC 500i Clinical Analyzer
- Check Part Number: C11137
- Cross-check serial numbers against the recall list provided by FDA
Where to find product info
FDA recall page for Z-0216-2026 and Beckman Coulter recall notice
What timeline to expect
Remediation timelines are coordinated by the manufacturer; typically weeks for replacement or service arrangements.
If the manufacturer is unresponsive
- Document all communications with Beckman Coulter
- Escalate to facility leadership and file a formal complaint with the FDA if needed
- Consult hospital risk management for interim patient safety measures
How to prevent similar issues
- Verify model numbers before installation or procurement
- Establish a formal process to install and verify software updates from manufacturers
- Maintain an up-to-date log of all device serial numbers and associated recalls
Documentation advice
Keep copies of the recall notice, serial number lists, and all communications with the manufacturer and regulatory bodies.
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Product Details
DxI 9000 Access Immunoassay Analyzer, Part Number C11137. DxC 500i Clinical Analyzer. UDI-DI: 15099590732103. Serial numbers: extensive list provided by recall. Quantity: 571 units. Distribution: Worldwide with US nationwide distribution. Sold worldwide; no retailer-specific listing available. Price: Not disclosed.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 571 units recalled worldwide
- Models: DxI 9000 Access Immunoassay Analyzer; DxC 500i Clinical Analyzer
- Part Number: C11137
- Serial numbers: extensive list provided by recall
- Recall date: 2025-09-19; Status: Active
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Safety Guide
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