Randox Laboratories, Limited FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. CatalClass IIDec 20, 2024Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does	Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.	Class IIDevices	Dec 20, 2024
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. CataloClass IIDec 20, 2024Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does	Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.	Class IIDevices	Dec 20, 2024