Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as R
Recalled Product
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Hazard / Issue
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 05055273204421 All lots within expiry
View official government recall
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