TEG 5000 Functional Fibrinogen Reagent — Class II medical device recall Z-1310-2022
Terminated recall by Haemonetics Corporation, reported 2022-07-06, distributed nationwide. Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are
| Recall number | Z-1310-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Boston, MA, United States |
| Recall initiated | 2022-04-26 |
| Classified | 2022-06-30 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2024-03-15 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 20812747018095 |
| Model numbers | 07-034 |
Product
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Reason for recall
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
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-1310-2022. 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.