Sysmex Corporation recalls The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vi…

Recall date

December 18, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1945-2016

FDA classification

Class II

Brand / firm

Sysmex Corporation

Sold / distributed

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, Ban…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.