Haemonetics Corporation 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.