Company: Haemonetics Corporation
Date of Enforcement Report: 6/28/2022
Class II

PRODUCT

Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay – PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)

Recall Number:

Z-1298-2022

REASON

When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

RECALLING FIRM/MANUFACTURER

Haemonetics Corporation on 4/19/2022. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

111

DISTRIBUTION

US Nationwide.