# FDA recall Z-1298-2022

> **Haemonetics Corporation** · Class II · device recall initiated 2022-04-19.

## 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)

## 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.

## Key facts

- **Recall number:** Z-1298-2022
- **Recalling firm:** Haemonetics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-19
- **Report date:** 2022-07-06
- **Termination date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1298-2022

## Citation

> AI Analytics. FDA recall Z-1298-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1298-2022. Source: US FDA. Licensed CC0.

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