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)

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.

Code information: This correction is applicable when TEG 5000 PlateletMapping (Item # 07-014, 07-015, 07-016) is performed on a TEG 5000 analyzer (Item # 07-022, 07-033) that is connected to TEG Manager Software which includes viewing of TEG 5000 results. Code Info: UDI-DI: (01)30812747018184 Software Version: TEGM 1.1 and later, TAS v4.2.3

Distribution pattern: US Nationwide.