BEUDAMED
    FDA Recall Open, Classified

    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

    Recall: Z-2357-2023 · Initiated June 5, 2023

    Recall

    Recall Number
    Z-2357-2023
    Event Number
    92662
    Firm
    ORTHO-CLINICAL DIAGNOSTICS Felindre Meadows Bridgend United Kingdom
    FEI Number
    3007111389
    Product Code
    MMI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 5, 2023
    Posted
    August 8, 2023

    Description

    VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

    Reason

    Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

    Action

    Customers were sent a recall notification by mail dated 06/05/2023. The notification that customers immediately discontinue use of affected devices and discard any remaining inventory. Any discarded product will be replaced by QuidelOrtho or credit will be provided. Customers are asked to return the provided Confirmation of Receipt Form no later than 06/12/2023. If affected devices were further distributed customers are asked to forward the provided notification to those downstream customers. This notice is to be posted by all VITROS Systems until the expiration of affected devices, which is 06/10/2023. Customers with any questions may contact Quidel Ortho at 1-800-421-3311.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    4,013 units