CLASS II ONGOING Device recall · Reported 8 Nov 2023 · FDA Enforcement Report

RX Modena-IVD Clinical Chemistry Analyser recalled

Randox Laboratories is recalling RX Modena-IVD Clinical Chemistry Analyser, distributed nationwide in the US. The recall was initiated on 6 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 05055273214963 Lot/Batch Number:

Quantity recalledO units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0201-2024
FDA event ID: 93102
Recalling firm: Randox Laboratories, Crumlin (North), N/A
Classification: Class II
Status: Ongoing
Recall initiated: 6 Sep 2023
FDA classified: 31 Oct 2023
Reported: 8 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

6 Sep 2023	Recall initiated by company
31 Oct 2023	Classified by FDA	+55 days
8 Nov 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000

Where it was distributed

US Nationwide distribution including Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN: 05055273214963 Lot/Batch Number:

Where was it sold?

US Nationwide distribution including Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 93102

Reported	Class	Recall	Company	Reason	Where
8 Nov 2023	CLASS II	RX Monaco-IVD Clinical Chemistry Analyser recalled	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023	CLASS II	RX Imola-IVD Clinical Chemistry Analyzer recalled by Randox Laboratories	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023	CLASS II	RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser recalled	Randox Laboratories	Potency & Assay	Nationwide
8 Nov 2023	CLASS II	RX Daytona Plus (without ISE)- IVD Clinical Chemistry recalled	Randox Laboratories	Potency & Assay	Nationwide

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