BEUDAMED
    FDA Recall Terminated

    TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies

    Recall: Z-1617-2020 · Initiated February 19, 2020

    Recall

    Recall Number
    Z-1617-2020
    Event Number
    85120
    Firm
    Haemonetics Corporation
    FEI Number
    1219343
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 19, 2020
    Terminated
    June 21, 2021
    Address
    125 Summer St, Boston, MA, 02110-1616

    Description

    TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies

    Reason

    Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.

    Action

    Haemonetics sent US customers using a TEG 5000 device and TEG Manager software a customer letter via email on February 19, 2020. This customer letter notified end users that Haemonetics is conducting a voluntary correction of all TEG Manager software used in conjunction with the TEG 5000 device. Letter states reason for recall, health risk and action to take: Haemonetics is developing a patch to correct the issue with the TEG Manager software. The patch is expected to be available in March of 2020. Haemonetics will contact customers when the TEG Manager software patch is available for download and we will follow up with each user to ensure that the patch has been received and implemented. In the meantime, customers using TEG Manager with the TEG 5000 device should continue to follow the instructions in the TEG 5000 user manual, which state that, Before making any decisions, the attendant physician must consider all clinical information about the patients condition, the procedure, and previous therapy. Users should rely on the actual value of each test result which is correctly displayed on the TEG 5000 and TEG Manager and should not make clinical decisions based solely on the out of range alerts displayed by TEG Manager software. Recipients of this notice should complete the attached acknowledgement form in its entirety.

    Distribution

    US Nationwide distribution.

    Quantity

    88 units