CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report

Randox Total Bilirubin recalled by Randox Laboratories

Randox Laboratories is recalling Randox Total Bilirubin, distributed nationwide in the US. The recall was initiated on 11 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.

Quantity recalled1644 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-0501-2024
FDA event ID: 93387
Recalling firm: Randox Laboratories, Crumlin (North)
Classification: Class II
Status: Ongoing
Recall initiated: 11 Oct 2023
FDA classified: 6 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 Oct 2023	Recall initiated by company
6 Dec 2023	Classified by FDA	+56 days
13 Dec 2023	Published in enforcement report	+7 days

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

Reason for recall

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

Product as listed by the FDA

RANDOX Total Bilirubin.

Where it was distributed

US Nationwide distribution in the states of AR, GA, NC, TN, & PR.

Nationwide Arkansas Georgia North Carolina Puerto Rico Tennessee

Questions about this recall

Why was it recalled?

Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.

Which lots are affected?

Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.

Where was it sold?

US Nationwide distribution in the states of AR, GA, NC, TN, & PR.

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.

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