Sysmex Corporation: Medical Device Recall in 2016 - (Recall #: Z-1945-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 18, 2014

Date Posted: June 22, 2016

Recall Number: Z-1945-2016

Event ID: 70054

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,137 units (US) 54 units (Canada) 9 inventory

Code Information:

1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484; 2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated