Devices

Device Recall Sysmex XE2100 Automated Hematology System

Model / Serial
catalog #983-1341-1, all serial numbers
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution: USA including Puerto Rico.
Product Description
Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 || The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method.
Manufacturer
Sysmex America, Inc.
1 Event
- Recall of Device Recall Sysmex XE2100 Automated Hematology System

Manufacturer

Sysmex America, Inc.

Manufacturer Address
Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
Manufacturer Parent Company (2017)
Sysmex Corp.
Source
USFDA

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