medical Class II Updated 2020-04-08

Haemonetics Corporation recalls TEG Manager software versions used in conjunction with TEG 5

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →