What is the risk to patients from this recall?

The software anomaly may cause false low or high test results due to incorrect dilution factors. This can lead to incorrect diagnoses if not identified.

Which devices are affected?

DxI 9000 Access Immunoassay Analyzer and DxC 500i Clinical Analyzer with Part Number C11137 and the listed serial numbers.

What should I do if my facility owns one of these devices?

Stop using the device immediately and follow Beckman Coulter's recall instructions. Consult your biosafety officer and clinical leadership.

How will I be refunded or compensated?

Refund or remediation will be arranged by Beckman Coulter per the recall notice. Contact the manufacturer for specific instructions.

How can I confirm my device is affected?

Check Part Number C11137, UDI-DI 15099590732103, and compare serial numbers against the recall list provided by FDA.

Where can I find official recall details?

FDA enforcement page lists the recall notice Z-0216-2026 and links to Beckman Coulter guidance.

Will software be updated to fix the issue?

Beckman Coulter will provide remediation guidance, which may include software updates or replacement options.

What is the time frame for remediation?

Remediation timelines vary by institution; manufacturers typically coordinate replacements or service within weeks.

Should labs continue testing during recall?

Labs should halt use of affected devices until guidance is issued by Beckman Coulter.

Who should be contacted for issues?

Contact Beckman Coulter for recall instructions. Use the FDA recall page for official updates.

HIGHSeptember 19, 2025

Beckman Coulter Recalls 571 DxI 9000 Immunoassay Analyzers and DxC 500i (2025)

Beckman Coulter recalled 571 DxI 9000 Access Immunoassay Analyzers and DxC 500i Clinical Analyzers distributed worldwide. A software anomaly may prevent correct application of manual dilution factors for tests already in progress on the same Sample ID. Labs should stop using the devices immediately and follow recall instructions.

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

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

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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
Check UDI-DI: 15099590732103
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.

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
UDI-DI: 15099590732103
Part Number: C11137
Serial numbers: extensive list provided by recall
Recall date: 2025-09-19; Status: Active

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeImmunoassay Analyzer

Product Details

Brand

Beckman Coulter

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