Beckman Coulter DxA Automation System — Class II medical device recall Z-2144-2023
Ongoing recall by Beckman Coulter Biomedical GmbH, reported 2023-07-26, distributed in AL, CA, FL, IL, IN, KY, MI, MN…. A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not
| Recall number | Z-2144-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Biomedical GmbH, Munchen, N/A, Germany |
| Recall initiated | 2023-06-02 |
| Classified | 2023-07-14 |
| Reported by FDA | 2023-07-26 |
| Distributed | AL, CA, FL, IL, IN, KY, MI, MN, MO, NE, NJ, NV, NY, OH, PA, SC, TX, WI, WV |
| Countries outside the US | AU, BE, CA, CH, CN, CZ, DE, EG, ES, FR, GB, GR, HK, HR, IE, IL, IT, KR, KW, MY, NL, NZ, PL, SA |
| Quantity | 146 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590707118 |
| Model numbers | 16A, 200240V, 50/60HZ, B87352 |
Product
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Reason for recall
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient 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-2144-2023. 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.