FDA recall Z-1717-2020

Product

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

Reason for recall

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.

Distribution

USA: FL, VT, IL.

Key facts

Status

Terminated

Initiation date

2020-01-21

Report date

2020-04-22

Termination date

2023-01-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mundelein, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2020