Devices

Device Recall Sysmex XN Series Automated Hematology Analyzers

Model / Serial
**Model: XN-10, Product Number: AP795756, Serial Numbers: 11001 29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867 **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, Canada
Product Description
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Manufacturer
Sysmex America Inc
1 Event
- Recall of Device Recall Sysmex XN Series Automated Hematology Analyzers

Manufacturer

Sysmex America Inc

Manufacturer Address
Sysmex America Inc, 577 Aptakisic Rd, Lincolnshire IL 60069-4325
Manufacturer Parent Company (2017)
Sysmex Corp.
Source
USFDA

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