Sysmex America, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1717-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 21, 2020

Date Posted: April 22, 2020

Recall Number: Z-1717-2020

Event ID: 84759

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.

Status: Terminated

Product Quantity: 40 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated