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Medium risk Medical DevicesClass II

Beckman Coulter DxH Diluent Recall

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-fre

Updated November 10, 2025

Certain lots of Beckman Coulter DxH Diluent products can cause elevated platelet counts in daily quality checks on blood cell counting systems. This may lead to inaccurate test results if not identified and corrected.

Is the Beckman Coulter, Inc. recalled? Yes. This product was recalled by FDA on November 10, 2025. Details below.

What is recalled

COULTER DxH Diluent REF 628017 and COULTER DxH ECO Diluent REF C67250. These products are used in UniCel DxH Coulter Cellular Analysis Systems and UniCel DxH Slidemaker Stainers for blood cell counting and analysis.

Am I affected

You are affected if you operate a medical lab or clinic using UniCel DxH Coulter Cellular Analysis Systems or UniCel DxH Slidemaker Stainers and have received diluent products with REF 628017 or REF C67250 from Beckman Coulter. Check the product reference numbers on your diluent bottles.

What to do right now

Contact Beckman Coulter, Inc. through the manufacturer or your distributor to identify whether your specific diluent lots are affected and to arrange replacement or guidance on corrective actions for your analyzer.

The hazard

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Brands affected

Beckman Coulter, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1221-2026
Classification
Class II
Recalled
November 10, 2025
Read the official notice

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