Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sysmex Recalled by Sysmex America Inc Due to Reported customer complaints of automated hematology analyzers catching...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sysmex America Inc directly.
Affected Products
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Quantity: 3,682 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sysmex America Inc
Sysmex America Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report