# FDA recall Z-1717-2020

> **Sysmex America, Inc.** · Class II · device recall initiated 2020-01-21.

## 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.

## Distribution

USA: FL, VT, IL.

## Key facts

- **Recall number:** Z-1717-2020
- **Recalling firm:** Sysmex America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-21
- **Report date:** 2020-04-22
- **Termination date:** 2023-01-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mundelein, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2020

## Citation

> AI Analytics. FDA recall Z-1717-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1717-2020. Source: US FDA. Licensed CC0.

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