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RX daytona plus RX4040Recalls & reported problems

Randox Laboratories Limited · The Randox RX daytona plus with ISE is a fully automated, random access, clinical chemistry analyser complete with dedicated analyser software. · Class 1

1 open recall names 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
1

Summary

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

1 FDA recall record name this device's identifier, 1 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. Sep 6, 2023Open, Classified

    RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

    Z-0198-2024 · Root cause: Under Investigation by firm · 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.