Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automa...
FDA Recall #Z-1017-2025 — Class II — December 20, 2024
Product Description
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Reason for Recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Recalling Firm
Randox Laboratories, Limited — Crumlin
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
15 kits
Distribution
US Nationwide distribution Including PR.
Code Information
UDI-DI: 05055273204421 All lots within expiry
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated