Recall Z-1617-2020— Haemonetics Corporation

Name: FDA recall Z-1617-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-19

Class II · Terminated

Class II FDA medical device recall by Haemonetics Corporation, initiated 2020-02-19, terminated 2021-06-21. It names one FDA 510(k) clearance: K002177. 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. 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..

Recalling firm: Haemonetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-02-19
Terminated: 2021-06-21
Firm location: Boston, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESHaemoscope Corp.·cleared 2000-09-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.