Quick Facts at a Glance
- Recall Date
- November 10, 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
- Diluent
- Model numbers
- Catalog Numbers: COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 UDI-DI code: 15099590233686 Lot Numbers: 2510410 2510420 2510450 3557500 3557510 3557540 3557560 3557570 3557640 3557650 3557660 3557670 3557680 3557700 3557710 3557850 3557920 3557930 3558000 3558030 3558040 3558060 3558090 3558100 3558110 3558120 3558140 3558150 3558160 3558170
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 10, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
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
The COULTER DxH Diluent is used as an isotonic buffered diluent for counting and sizing blood cells in clinical laboratories. Healthcare providers typically use this product in conjunction with blood analyzers to ensure accurate blood testing results.
Why This Is Dangerous
The specific lots of diluents in question have been found to contribute to elevated platelet background counts, which can distort test results and lead to false readings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on accurate blood cell analysis may face misdiagnosis, which can affect treatment decisions. Immediate cessation of use is crucial to prevent potential health risks.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for catalog numbers: REF 628017 and REF C67250.
- Verify the lot numbers against the recalled list.
- Contact your healthcare provider for assistance in identifying the product.
Where to find product info
Look for the catalog numbers and lot numbers on the product label or packaging to verify if your diluent is affected by the recall.
What timeline to expect
Expect a timeline of 4-8 weeks for processing refunds or replacements after contacting Beckman Coulter.
If the manufacturer is unresponsive
- Document all correspondence with Beckman Coulter.
- Follow up with their customer service if you do not receive a timely response.
- Consider reporting the issue to the FDA if necessary.
How to prevent similar issues
- Always verify the lot numbers and catalog numbers of medical devices before use.
- Stay informed about recalls through official health department channels.
- Consult with healthcare providers about any product concerns.
Documentation advice
Keep records of your purchase, including receipts and any communication with Beckman Coulter regarding the recall.
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Product Details
The recalled products include COULTER DxH Diluent, REF 628017 and COULTER DxH ECO Diluent, REF C67250. These diluents were distributed worldwide, including states such as California, Texas, and New York, and countries like Canada, Argentina, and Vietnam.
Key Facts
- Recalled diluents include REF 628017 and REF C67250
- Stop using the product immediately
- Contact Beckman Coulter for instructions
- No reported injuries or deaths
- Distributed worldwide, affecting numerous states and countries
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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