COULTER DxH Diluent — Class II medical device recall Z-2138-2023
Ongoing recall by Beckman Coulter, Inc., reported 2023-07-19, distributed nationwide. Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specificat
| Recall number | Z-2138-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Miami, FL, United States |
| Recall initiated | 2023-05-31 |
| Classified | 2023-07-12 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BO, BR, CA, CL, CO, EC, HK, ID, KW, MX, PA, PE, TT, TW, UY, VN |
| Model numbers | 628017 |
Product
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Reason for recall
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
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-2138-2023. 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.