RANDOX Total Bilirubin — Class II medical device recall Z-0501-2024
Ongoing recall by Randox Laboratories Ltd., reported 2023-12-13, distributed nationwide. Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin
| Recall number | Z-0501-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2023-10-11 |
| Classified | 2023-12-06 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,644 units |
| UPC / GTIN / UDI-DI | 05055273208337, 05055273214765, 05055273214772 |
| Model numbers | BR4061, BR8377, BR9766 |
Product
RANDOX Total 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0501-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.