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 | 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. |
| Product | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 |
| Quantity | 3933 kits (US); 2429 kits (OUS) |
| Distribution | Domestic distribution US Nationwide. |
| Initiated | 2022-04-26 |
| Classified | 2022-06-30 |
| Terminated | 2024-03-15 |
| Recall number | Z-1310-2022 |
| 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-1310-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90323/
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