Sysmex CV-11 Sample Unit — Class II medical device recall Z-1717-2020
Terminated recall by Sysmex America, Inc., reported 2020-04-22, distributed in FL, IL, VT. When excessive amounts of urine spills on the rack transport track and reaches the electrical components of th
| Recall number | Z-1717-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America, Inc., Mundelein, IL, United States |
| Recall initiated | 2020-01-21 |
| Classified | 2020-04-15 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2023-01-30 |
| Distributed | FL, IL, VT |
| Quantity | 40 units |
| Serial numbers | 11201, 11202, 12310, 12311, 12312, 12313, 12941, 12942, 12997, 13875, 14170, 14171, 14172, 14173, 14174, 14175, 14278, 14279, 14280, 14962, 14963, 14964, 14965, 14966, 14967 and 15 more |
Product
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
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 combustion hazard.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1717-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.