Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Recalled by Randox Laboratories, Limited Due to Lipoprotein (a) on Roche Cobas c501 with nmol/l...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Randox Laboratories, Limited directly.
Affected Products
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Quantity: 33 kits
Why Was This Recalled?
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Randox Laboratories, Limited
Randox Laboratories, Limited has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report