FDA Device recall Z-1796-2013
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
- FDA Device
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies by Haemonetics, citing research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1796-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-20 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Haemonetics |
| Distribution | US |
Product
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Reason
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Identifiers
| code_info | Per recall strategy. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1796-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.