BEUDAMED
    FDA Recall Open, Classified

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

    Recall: Z-1018-2025 · Initiated December 20, 2024

    Recall

    Recall Number
    Z-1018-2025
    Event Number
    96043
    Firm
    Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
    FEI Number
    1000361607
    Product Code
    DFC
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    December 20, 2024
    Posted
    January 23, 2025

    Description

    Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

    Reason

    Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

    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 [email protected] 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.

    Distribution

    US Nationwide distribution Including PR.

    Quantity

    33 kits