Recall Z-1017-2025 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Randox Laboratories, Limited
Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403
| Date | Jan 23, 2025 (initiated Dec 20, 2024) |
| Status | Open, Classified |
| Reason | Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA. |
| Root cause | No Marketing Application |
| Action | Randox Laboratories Ltd (manufacturer) extended recall to the distribution center in the USA via email on 12/20/24. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any copies of Roche Cobas c501 ISA listing nmol/1 claims. " Ensure clinical results are no longer reported in nmol/1 using the Roche Cobas c501 nmol/1 claims. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety No |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution Including PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011568 | RANDOX LIPOPROTEIN Randox Laboratories, Ltd., Sep 28, 2001 |