TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage:… — Class II medical device recall Z-1796-2013
Terminated recall by Haemonetics Corporation, reported 2013-07-31, distributed nationwide. Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
| Recall number | Z-1796-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haemonetics Corporation, Braintree, MA, United States |
| Recall initiated | 2013-06-20 |
| Classified | 2013-07-24 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2015-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,590 devices |
Product
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Reason for recall
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
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-1796-2013. 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.