BEUDAMED
    FDA Recall Terminated

    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

    Recall: Z-1310-2022 · Initiated April 26, 2022

    Recall

    Recall Number
    Z-1310-2022
    Event Number
    90323
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2022
    Terminated
    March 15, 2024
    Address
    125 Summer St, Boston, MA, 02110-1616

    Description

    TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

    Reason

    Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.

    Action

    On April 26, 2022, affected customers were provided with a recall letter via email. Customers may continue to use the TEG 5000 Functional Fibrinogen reagent with the current IFU in conjunction with the letter which reflects the updated ranges. Haemonetics will provide a revision to the IFU. Additionally, customers using Functional Fibrinogen reagent are being reminded to continue to follow the instructions in the current Instructions for Use (118474-MULTI (XX)), which state - Results from the TEG analyzer should not be the sole basis for a patient diagnosis TEG analyzer results should be considered along with a clinical assessment of the patient's condition and other coagulation laboratory tests.

    Distribution

    Domestic distribution US Nationwide.

    Quantity

    3933 kits (US); 2429 kits (OUS)