Skip to content

RX monaco RX5000Recalls & reported problems

Randox Laboratories Limited · The RX monaco Analyser is a fully automated clinical chemistry analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary, food and wine laboratories. The RX monaco can detect a wide range of analytes in various liquid matrices. These include serum, plasma, urine, CSF and supernatants. The RX monaco is designed to be used by qualified laboratory staff, in conjunction with current Randox clinical chemistry reagents, to generate a result. The results that are generated are intended to be interpreted by a trained professional to aid in the diagnosis or interpretation of its application. The RX monaco is supplied with dedicated software that has been designed to assist and guide the operator through the operational processes. The software allows the RX monaco to interface with a host system or computer to assist in the processing, storing, ordering and managing of tests and test results. · 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-0202-2024 · 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.