medical Class II Updated 2025-01-29

Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Ra

Recalled Product

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


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: 05055273209198 All lots within expiry
View official government recall

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