Official recall record

RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)

US FDA — Medical Devices · 2023-09-06 · IrelandClass II

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): 05055273206104
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.

More recalls: US FDA — Medical Devices · Ireland · all filters

Same barcode in other registries

The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2018-05-04 · US FDA — Medical Devices
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry test
2021-04-28 · US FDA — Medical Devices
Randox RX Imola Analyser with ISE, Catalog Numbers RX4900, RX4900R

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 →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.