Beckman Coulter Recalls 160 DxC 500i Modules and DxI 9000 Analyzers in 2025 Recall

How to identify if yours is affected

1. 1) Confirm device model numbers C63522, C63521, or C13252.
2. 2) Verify serial numbers against the recall serial list.
3. 3) Check for any recall communications from Beckman Coulter.
4. 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.