Apr

2020

Recall – Assay analyzer software defect erroneously causes out of range alert

Company: Haemonetics Corporation
Date of Enforcement Report: 4/8/2020
Class II

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

Recall Number: Z-1617-2020

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/MANUFACTURER

Haemonetics Corporation on 2/19/2020. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

88 units

DISTRIBUTION

US Nationwide

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Recall – Assay analyzer software defect erroneously causes out of range alert

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