Randox Lipoprotein (a) Diagnostic Assay Lacks FDA Clearance, Recalled
Randox Laboratories is recalling 33 Randox Lipoprotein (a) diagnostic kits nationwide. The assay's claims for use on Roche Cobas c501 analyzers lack required FDA clearance or approval.
- Product
- Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
- Category
- Medical Device
- Distribution
- Distributed nationwide