BEUDAMED
    FDA Recall Terminated

    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979

    Recall: Z-1699-2020 · Initiated March 4, 2020

    Recall

    Recall Number
    Z-1699-2020
    Event Number
    85167
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    GGP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 4, 2020
    Terminated
    November 10, 2021
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979

    Reason

    A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased

    Action

    Stago notified on 3/4/20 end users of the risks to factor VIII tests in writing. Letters issued via email, US mail, and/or UPS overnight mail. Letter states reason for recall, health risk and action to take: To remove this cross-contamination risk, a special pre-wash has been developed for the concerned Stago methodology. It involves special washing of needle 1 before every factor VIII assay in order to eliminate any residual quantities of Emicizumab. This cleaning sequence has been implemented in the stated available software versions. Customers not possessing these software levels will be upgraded by Stago Field Support personnel. Completed enclosed acknowledgement coupon to Stago confirming you have read the letter and will apply the instructions Please fax to 1-973-644-9348 or e-mail [email protected]. For additional information, please contact your Stago Hotline at 1-800-725-0607. In addition- Since the Stago analyzer platforms are open systems, analyzer customers may be performing other factor VIII assays (e.g. LDTs, or other manufacturers factor VIII products) that Stago has no visibility to, or control over. Therefore an Information Letter issued to all other US customers of the analyzers, to alert customers to the risk that factor VIII testing on these Stago analyzers can be affected by the Emicizumab molecule, and to contact technical service teams for assistance.

    Distribution

    Nationwide

    Quantity

    3,225 units