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
- DxC 500i Clinical Analyzer Modules and DxI 9000 Access Immunoassay Analyzer
- Model numbers
- C63522, C63521, C13252
- 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
DxC 500i modules and the DxI 9000 Access Immunoassay Analyzer are clinical laboratory instruments used for chemistry and immunoassay testing in healthcare settings.
Why This Is Dangerous
A software anomaly can misapply manual dilution factors for tests ordered on samples in progress, risking inaccurate results and delayed reporting.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The defect could lead to incorrect patient results and reporting delays, potentially impacting diagnosis and treatment.
Practical Guidance
How to identify if yours is affected
- 1) Confirm device model numbers C63522, C63521, or C13252.
- 2) Verify serial numbers against the recall serial list.
- 3) Check for any recall communications from Beckman Coulter.
- 4) Quarantine affected devices and contact Beckman Coulter for instructions.
Where to find product info
Recall notice and enforcement page at the FDA link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0215-2026
What timeline to expect
Resolution or remediation guidance will be provided by Beckman Coulter through the recall letter. Expect weeks to months depending on device and site.
If the manufacturer is unresponsive
- Escalate to institutional biosafety or biomedical engineering leadership.
- File a formal request for remediation with Beckman Coulter if no response within stated timeframes.
- If needed, consult regulatory authorities for guidance on device safety.
How to prevent similar issues
- Only install software updates released by Beckman Coulter through official channels.
- Periodically verify test dilution procedures in practice to minimize risk before remediation is available.
- Maintain an inventory of affected devices and store recall communications securely.
Documentation advice
Keep the recall notification, serial/model lists, and all correspondence with Beckman Coulter for future reference.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Models C63522, C63521, C13252
- Serial numbers listed in recall
- Software anomaly affects manual dilution factors
- Hospital/clinical facility users should stop use immediately
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.