FDA Device recall Z-2145-2023
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly by Beckman Coulter Biomedical, citing 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 resu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2145-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-02 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter Biomedical |
| Distribution | AL, CA, FL, IL, IN, KY, MI, MN, MO, NE, NJ, NV, NY, OH, PA, SC, TX, WI, WV |
Product
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Reason
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
Identifiers
| code_info | UDI-DI: (01)15099590707118, All DxA serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2145-2023%22
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