Beckman Coulter UniCel Dxl 800 — Class II medical device recall Z-1026-2026
Ongoing recall by Beckman Coulter, Inc., reported 2026-01-14, distributed nationwide. Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may no
| Recall number | Z-1026-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-11-26 |
| Classified | 2026-01-06 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DO, DZ, EG, ES, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, LB, LT, MA, MX, MY, NG, NL, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UA, VN, ZA |
| Quantity | 6,457 units |
| UPC / GTIN / UDI-DI | 15099590194819, 15099590265373, 15099590369194, 15099590369231, 16954701000412 |
| Model numbers | 973100, A25288, A71456, A71457 |
Product
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Reason for recall
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
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-1026-2026. 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.