Class II

Medical Device Recall: Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

Randox Laboratories, Limited · December 20, 2024

Reason for Recall

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

Distribution

US Nationwide distribution Including PR.

States Affected

NATIONWIDE

Quantity Affected

33 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1018-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.