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 | Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter. |
| Product | Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System. |
| Quantity | 4,143 kits |
| Distribution | Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden. |
| Initiated | 2015-01-26 |
| Classified | 2015-02-19 |
| Terminated | 2015-06-05 |
| Recall number | Z-1130-2015 |
| 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-1130-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70352/
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