RANDOX Total Bilirubin recallZ-0501-2024 · Randox Laboratories Ltd. · initiated Oct 11, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0501-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 11, 2023
- Posted by the FDA
- Dec 6, 2023
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1644 units
- Product code
- JFM
- FDA submissions
- K152344
- Distribution
- US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Product description
RANDOX Total Bilirubin.
Code information (models, lots, serial numbers)
Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- T BIL BR9766Randox Laboratories Limited · Enzymatic Method, Bilirubin1 recall0 reports
- TOTAL BILIRUBIN 2 (T BIL 2) BR8377Randox Laboratories Limited · Enzymatic Method, Bilirubin1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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