Drug recall
RANDOX Total Bilirubin.
FDA recall event 93387 · Class II · Randox Laboratories Ltd.
Key facts
| Event ID | 93387 |
|---|---|
| Recall numbers | Z-0501-2024 |
| Recalling firm | Randox Laboratories Ltd. |
| Product type | Devices |
| Products | RANDOX Total Bilirubin. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. |
| Initiation date | Oct 11, 2023 |
| Report date | Dec 13, 2023 |
| City | Crumlin (North) |
| Country | Ireland |
| FEI number | 2965 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: