COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

Recall Insight

This FDA Devices action (record #Z-1221-2026) was formally reported on February 11, 2026, with the manufacturer initiating the action on November 10, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter, Inc. is listed as the recalling firm, operating out of Miami, FL. Federal records indicate 76,098 units (US-61843 and OUS-14255) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. Distribution data in the federal record shows the product reached: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PA, Puerto …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.