Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1617-2020 — 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

U.S. FDA — Device Enforcement · United States · 2020-02-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1617-2020
Date of alert
2020-02-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Haemonetics Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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