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Sysmex Corporation recalls The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vit
Recalled June 22, 2016 · FDA recall Z-1945-2016 · Sysmex
Hazard
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. · FDA Class II
Units
1,137 units (US) 54 units (Canada) 9 inventory
Sold at
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.
Description
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Product
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.
Manufacturer(s)
Sysmex Corporation
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →