FDA-Device2020-04-22Class II
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Sysmex America, Inc.
Hazard
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.
Sold states
USA: FL, VT, IL.
Affected count
40 units
Manufactured in
1 Sysmex Way, Mundelein, IL, United States
Products
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2020Don't want to check this manually?
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