Quick Facts at a Glance
- Recall Date
- August 4, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Clinical Analyzer Module
- Model numbers
- C63522, C63521, SW 1.3.3, SW 1.3.4
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 4, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
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 Clinical Analyzer family processes multiple clinical tests including Clinical Chemistry and Immunoassay. The affected modules enable testing on the analyzer.
Why This Is Dangerous
Misordered CC and IA tests can cause CC status to stay In Progress, delaying results without error messages.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Delays may impact patient care timelines and lab workflows; no injuries or patient harm reported in the recall data.
Practical Guidance
How to identify if yours is affected
- Check if your DxC 500 AU Module with ISE or DxC 500i is REF C63522 or C6352.
- Verify software versions SW 1.3.3 or 1.3.4.
- Review your device purchase and installation dates.
Where to find product info
Manufacturer recall letter and FDA recall page linked in notice.
What timeline to expect
Refunds or replacements are provided per Beckman Coulter notice; handling timelines not specified in data.
If the manufacturer is unresponsive
- Document all communications with Beckman Coulter.
- Escalate to hospital risk management or vendor representative if no response within 2 weeks.
How to prevent similar issues
- Verify test order workflows to minimize cross-test timing.
- Keep software updated within approved versions.
- Establish lab protocol for concurrent CC and IA testing.
Documentation advice
Retain recall letter, IT/system logs showing test sequencing, all correspondence with Beckman Coulter.
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Product Details
Model numbers include REF/UDI-DI: C63522/14987666545089 and C63521/14987666545072. Software versions affected: SW 1.3.3 and 1.3.4. Distribution countries include Poland, India, Dominican Republic, Lebanon, Italy, Brazil, El Salvador, Saudi Arabia, Germany, France, Nepal, Canada, Chile, Spain, Malaysia, Switzerland, Morocco, Philippines, Curacao, Qatar, United Arab Emirates, Hungary, Czechia, Oman, New Zealand, Thailand, Indonesia, Algeria, United Kingdom, Namibia, Turkey, Republic of Korea.
Reported Incidents
No data on injuries or fatalities is provided in the recall notice.
Key Facts
- 116 total units recalled
- DxC 500 AU Module with ISE and DxC 500i components affected
- Ref: C63522 and C6352
- Software SW 1.3.3 and 1.3.4
- International distribution to 30+ countries
- High hazard level
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Safety Guide
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