Class II — Sysmex America, Inc.
| Recalling firm | SYSMEX CORPORATION |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard. |
| Product | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. |
| Quantity | 40 units |
| Distribution | USA: FL, VT, IL. |
| Initiated | 2020-01-21 |
| Classified | 2020-04-15 |
| Terminated | 2023-01-30 |
| Recall number | Z-1717-2020 |
| 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 — Sysmex America, Inc. (Z-1717-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84759/
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