Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The XN-Series modules (XN-10 Recalled by Sysmex Corporation Due to There is a potential for elevated hemoglobin (Hgb)...
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 Corporation directly.
Affected 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.
Quantity: 1,137 units (US) 54 units (Canada) 9 inventory
Why Was This Recalled?
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
Where Was This Sold?
This product was distributed to 49 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI, WY
About Sysmex Corporation
Sysmex Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report