Drug recall
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10…
FDA recall event 84759 · Class II · Sysmex America, Inc.
Key facts
| Event ID | 84759 |
|---|---|
| Recall numbers | Z-1717-2020 |
| Recalling firm | Sysmex America, Inc. |
| Product type | Devices |
| Products | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Jan 21, 2020 |
| Report date | Apr 22, 2020 |
| Termination date | Jan 30, 2023 |
| City | Mundelein |
| State | IL |
| Country | United States |
| FEI number | 1000515253 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: