Skip to content

DxA 5000Recalls & reported problems

Beckman Coulter, Inc. · DxA 5000 · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 2, 2023Open, Classified

    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

    Z-2145-2023 · Root cause: Software design · FDA record ↗

  2. Jun 2, 2023Open, Classified

    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

    Z-2144-2023 · Root cause: Software design · FDA record ↗

Other Analyzer, Chemistry (Photometric, Discrete), For Clinical Use devices

All Analyzer, Chemistry (Photometric, Discrete), For Clinical Use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.