Recall Z-1717-2020— Sysmex America, Inc.

Name: FDA recall Z-1717-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-21

Class II · Terminated

Class II FDA medical device recall by Sysmex America, Inc., initiated 2020-01-21, terminated 2023-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.. 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..

Recalling firm: Sysmex America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Terminated: 2023-01-30
Firm location: Mundelein, IL, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.