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Randox Laboratories, Limited
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Randox Laboratories, Limited and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-29FDA-DeviceClass IIRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
- 2025-01-29FDA-DeviceClass IIRandox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
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