FDA Device recall Z-0501-2024
RANDOX Total Bilirubin
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of RANDOX Total Bilirubin by Randox Laboratories, citing randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0501-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-11 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
RANDOX Total Bilirubin.
Reason
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Identifiers
| code_info | Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0501-2024%22
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