BEUDAMED
    FDA Recall Terminated

    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

    Recall: Z-1298-2022 · Initiated April 19, 2022

    Recall

    Recall Number
    Z-1298-2022
    Event Number
    90358
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 19, 2022
    Terminated
    March 27, 2024
    Address
    125 Summer St, Boston, MA, 02110-1616

    Description

    Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

    Reason

    When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

    Action

    On April 22, 2022, the firm notified affected customers of the recall via email. Customers were asked to complete and return the attached acknowledgement form. Upon receipt, Haemonetics will contact the customer to arrange the remote installation of the updated software, version 4.4.0, which will resolve the issue.

    Distribution

    US Nationwide.

    Quantity

    111