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Sysmex America, Inc. recalls Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Recalled April 22, 2020 · FDA recall Z-1717-2020 · Sysmex America
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. · FDA Class II
Units
40 units
Sold at
USA: FL, VT, IL.
Description
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.
Product
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.
Manufacturer(s)
Sysmex America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →