Class II — Haemonetics Corporation
| Recalling firm | Haemonetics Corporation |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Research Use Only (RUO) parameters were included in TEG 5000 User Manual. |
| Product | TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies |
| Quantity | 1590 devices |
| Distribution | US Nationwide |
| Initiated | 2013-06-20 |
| Classified | 2013-07-24 |
| Terminated | 2015-06-04 |
| Recall number | Z-1796-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Haemonetics Corporation (Z-1796-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65635/
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