Product Name: TEG5000 Analyzer — Class II medical device recall Z-1298-2022
Terminated recall by Haemonetics Corporation, reported 2022-07-06, distributed nationwide. When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays a
| Recall number | Z-1298-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Boston, MA, United States |
| Recall initiated | 2022-04-19 |
| Classified | 2022-06-28 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2024-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 111 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 30812747018184 |
| Model numbers | 07-014, 07-015, 07-016, 07-022, 07-033 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1298-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.