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
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1221-2026
- Classification
- Class II
- Recalled
- November 10, 2025
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