COULTER DxH Diluent — Class II medical device recall Z-1221-2026
Ongoing recall by Beckman Coulter, Inc., reported 2026-02-11, distributed nationwide. Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with u
| Recall number | Z-1221-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2025-11-10 |
| Classified | 2026-01-30 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CA, CL, MX, TT, VN |
| UPC / GTIN / UDI-DI | 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 |
| Model numbers | 628017, C67250 |
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 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.
Reason for recall
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1221-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.