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.
