FDAJanuary 21, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

sysmex americasysmex

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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