Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Reported: April 22, 2020 Initiated: January 21, 2020 #Z-1717-2020
Product Description
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.
Details
- Recalling Firm
- Sysmex America, Inc.
- Units Affected
- 40 units
- Distribution
- USA: FL, VT, IL.
- Location
- Mundelein, IL
Frequently Asked Questions
What product was recalled? ▼
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.. Recalled by Sysmex America, Inc.. Units affected: 40 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2020. Severity: Moderate. Recall number: Z-1717-2020.
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