Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757
This recall is currently active, issued January 23, 2025. It was issued by Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom.
- Recall Initiated
- December 20, 2024
- Posted
- January 23, 2025
- Recall Number
- Z-1018-2025
- Quantity
- 33 kits
- Official Source
- View on FDA website ↗
Reason for Recall
Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
Distribution
US Nationwide distribution Including PR.
Lot / Code Info
UDI-DI: 05055273209198 All lots within expiry
Root Cause
No Marketing Application
Action Taken
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 Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns please contact Randox Technical Services.