BEUDAMED
    FDA Recall Open, Classified

    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

    Recall: Z-0415-2026 · Initiated October 1, 2025

    Recall

    Recall Number
    Z-0415-2026
    Event Number
    97745
    Firm
    Microgenics Corporation
    FEI Number
    3010939897
    Product Code
    JJY
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 1, 2025
    Posted
    October 30, 2025
    Address
    46500 Kato Rd, Fremont, CA, 94538-7310

    Description

    Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

    Reason

    The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

    Action

    ThermoFisher Scientific issued an URGENT -MEDICAL DEVICE RECALL notice to its consignees on 10/02/2025 via email. The notice explained the issue, risk to health, and requested the following: "ACTIONS TO BE TAKEN BY A USER 1. If you are a user of the High sensitivity Troponin I Assay, determine if you have inventory of the affected lots of MAS Omni"CARDIO" control as listed in Table 1. As stated in the instructions for use, instrument values provided are specific to this lot of control only and are intended to assist the laboratory in establishing its own means and ranges. 2. You may continue to use controls that meet your laboratory s performance requirements. 3. If the variability of the material exceeds your laboratory s specification, dispose of the material in accordance with local, regional, and national regulations. After disposing of the material, contact [email protected] for a credit. 4. Customers using the affected product with standard/ regular Troponin I assays, can continue to use the product as long as it meets their laboratory s specification and continue monitoring performance of Troponin I in MAS Omni"CARDIO" control. 5. This recall notice needs to be passed to anyone within your organization or any organization where the potentially affected lots have been transferred. 6. Retain a copy of this letter for your laboratory records. 7. Please complete the Recall Response Form attached to this Notification within 10 days of the date of this letter and return to Thermo Fisher as instructed in the form to E-mail:[email protected] 8. If you have any additional questions regarding this Recall Notice, contact Thermo Fisher Scientific Technical Support at toll free 1-800-232-3342 (USA and Canada only) or 510-979-5000 (International), Option 2, then option 3 or by email: [email protected]." "ACTIONS TO BE TAKEN BY A DISTRIBUTOR 1. Please notify your customers of this Recall Notice using this recall notice and request t

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.

    Quantity

    4462