Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1017-2025 — Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

U.S. FDA — Device Enforcement · United Kingdom · 2024-12-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1017-2025
Date of alert
2024-12-20
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories, Limited
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273204421
Reported risk: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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