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Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal
Recalled January 29, 2025 · FDA recall Z-1017-2025 · Randox Laboratories
Hazard
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. · FDA Class II
Units
15 kits
Sold at
US Nationwide distribution Including PR.
Description
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Manufacturer(s)
Randox Laboratories, Limited
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →