Official recall record
RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-09-06
- Country of alert
- Ireland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05055273207750
- Brand on record
- Randox Laboratories Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2024-04-05 · US FDA — Medical Devices
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug mol - 2023-11-29 · US FDA — Medical Devices
RX Series Copper (Cu) Assay Ref. Number CU2340
All 7 official recall notices naming Randox Laboratories Ltd. on this site →
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