Home / Recalls / Haemonetics Corporation / Z-1617-2020

Z-1617-2020 Class II Terminated

Recalled by Haemonetics Corporation — Boston, MA

Recall Details

Product Type
Devices
Report Date
April 8, 2020
Initiation Date
February 19, 2020
Termination Date
June 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
88 units

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.

Distribution Pattern

US Nationwide distribution.

Code Information

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.

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  • Z-1298-2022 Class II — Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07 (April 19, 2022)
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