Haemonetics Corporation: 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), PlateletMappi

Is my product affected?

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 v

• UPC 30812747018184

Check against the official notice below — it lists the full affected range.

What happened

Haemonetics Corporation recalled 111 TEG 5000 Analyzers used with PlateletMapping assays (both ADP and AA versions) when connected to TEG Manager Software. The devices may display incorrect values for PlateletMapping % Inhibition and % Aggregation results, affecting the accuracy of test results shown in TEG Manager. The recall applies to specific analyzer models (07-022, 07-033) with TEG Analytical Software versions 4.2.3 and later, connected to TEG Manager Software version 1.1 and later, and distributed nationwide in the United States.

The source document does not specify what remedy affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide. Quantity: 111 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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