Drug recall
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers…
FDA recall event 96043 · Class II · Randox Laboratories, Limited
Key facts
| Event ID | 96043 |
|---|---|
| Recall numbers | Z-1017-2025, Z-1018-2025 |
| Recalling firm | Randox Laboratories, Limited |
| Product type | Devices |
| Products | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757, Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| Initiation date | Dec 20, 2024 |
| Report date | Jan 29, 2025 |
| City | Crumlin |
| Country | United Kingdom |
| FEI number | 1000361607 |
At a glance
- 1–9 Products in this recall
- 1–9 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: