The Recall Desk
Severity pendingFDA (Devices)·Z-1221-2026·Announced 2026-02-11

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffer

Pending LLM rewrite. Source: FDA_DEVICE Z-1221-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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

The recalled product

Product
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
Manufacturer
Beckman Coulter, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog Numbers: COULTER DxH Diluent

Distribution

Distributed nationwide across the United States.