FDA-Device2017-05-10Class II
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Sysmex America Inc
Hazard
Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
Sold states
Nationwide, Canada
Affected count
3,682 units
Manufactured in
577 Aptakisic Rd, Lincolnshire, IL, United States
Products
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2034-2017Don't want to check this manually?
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