BEUDAMED
    FDA Recall Open, Classified

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    Recall: Z-1585-2026 · Initiated February 5, 2026

    Recall

    Recall Number
    Z-1585-2026
    Event Number
    98362
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    DAP
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 5, 2026
    Posted
    March 19, 2026
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    Reason

    After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

    Action

    On February 5, 2026 QUALITY ALERT letters were emailed to customers. Actions required: 1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents. 2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form. In the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document Medical Device Reporting for User Facilities, which is available on the FDA.gov website, for instructions. For additional information, please contact Stago s 24/7 Hotline at 1-800-725-0607.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.

    Quantity

    34000 units (28446 US, 5554 OUS)