Z-0501-2024Class II

RANDOX Total Bilirubin

Name: Z-0501-2024 RANDOX Total Bilirubin
Creator: Randox Laboratories Ltd.
Published: 2023-10-11
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2023-10-11 / Open, Classified / root cause: design

FDA source

Randox Laboratories Ltd. began a recall of RANDOX Total Bilirubin on 2023-10-11. FDA classified it as Class II and gives the reason as "Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0501-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-11
Posted: 2023-12-06
Recalling firm: Randox Laboratories, Limited
Product: RANDOX Total Bilirubin.
Product code: JFM Enzymatic Method, Bilirubin
Reason for recall: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were emailed an Urgent Device Correction letter on 10/11/2023. The notice instructed consignees to only use Total Bilirubin Vanadate Oxidation Method on Serum samples, to review results generated with Plasma samples in like with the clinical profiles of the patient, discuss the contents of the recall notice with your facility's Medical Director, and to return the provided response form completed to [email protected] within 5 working days. The recall notice is to be further distributed to all affected customers and those within consignee organizations, if further distributed. A second recall notification, dated 4/26/24, was sent to consignees identifying the reason for the product issue to be intralipid interference. Reagent IFUs have been updated with sample specific Plasma (lithium heparin) interference claims for intralipids, which can be found on www.randox.com. Consignees are asked to complete and return the provided response form to [email protected] within five working days.
Quantity in commerce: 1644 units
Distribution: US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Product codes and lots: Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0501-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0501-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-06

Product code JFM

K152344Class IITotal BilirubinRandox Laboratories Limited / cleared 2016-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)