FDA-Device2016-06-22Class II

The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Sysmex Corporation
Hazard

There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

Sold states
Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.
Affected count
1,137 units (US) 54 units (Canada) 9 inventory
Manufactured in
1 5 1 Wakinohamakaigandoori, CHUO-KU, Kobe-shi, Japan
Products
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2016

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