Devices

Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

Model / Serial
Software versions 1.0, 1.01, 1.1.1, 1.1.2
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IS, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA and WI and the country of Canada.
Product Description
The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis. The instrument can perform screening for abnormal samples with a high degree of accuracy, so it increases automation and efficiency in laboratories.
Manufacturer
Sysmex America, Inc.
1 Event
- Recall of Device Recall Sysmex UF1000i Automated Urine Particle Analyzer with Urinalysis WAM

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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