HIGH

Beckman Coulter Recalls Diluent Due to Elevated Platelet Counts

Beckman Coulter recalled 76,098 units of COULTER DxH Diluent on November 10, 2025. The recall affects specific lots contributing to elevated platelet background counts in analyzers. Healthcare providers and patients must stop using this product immediately.

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

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

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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

  1. Check the product packaging for catalog numbers: REF 628017 and REF C67250.
  2. Verify the lot numbers against the recalled list.
  3. 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.

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
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

Product TypeDiluent
Sold At
Multiple Retailers

Product Details

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
Affected States
ALL
Report Date
February 11, 2026
Recall Status
ACTIVE

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