medical Class II Updated 2020-04-22

Sysmex America, Inc. recalls Sysmex CV-11 Sample Unit, an integrated modular sampler that

Recalled Product

Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.

Hazard / Issue

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.

Issued by

FDA

Affected States: FL, VT, IL

Lot/Code Info: 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, 14968, 14969, 14970, 14972, 14973, 14974, 14975, 14976, 14977, 14978, 14979, 15017, 15018, 15619, 15620

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