FDA-Device2020-04-08Class II
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
Haemonetics Corporation
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
88 units
Manufactured in
125 Summer St, N/A, Boston, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2020Don't want to check this manually?
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