FDA Devices Moderate Class II Ongoing

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

Reported: January 29, 2025 Initiated: December 20, 2024 #Z-1017-2025

Product Description

Reason for Recall

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Details

Recalling Firm: Randox Laboratories, Limited
Units Affected: 15 kits
Distribution: US Nationwide distribution Including PR.
Location: Crumlin

Frequently Asked Questions

What product was recalled? ▼

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403. Recalled by Randox Laboratories, Limited. Units affected: 15 kits.

Why was this product recalled? ▼

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-1017-2025.

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