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Recall Observatory FDA recall evidence

Device product

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

Z-1717-2020

January 21, 2020

Class II

Product summary

Firm
Sysmex America, Inc.
Event
Event 84759
Status
Terminated
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-1717-2020

Official wording

Reason: 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.

Code information: 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

Distribution pattern: USA: FL, VT, IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.