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Z-1945-2016 Class II Terminated

Recalled by Sysmex Corporation — Kobe-shi

FDA device recall Z-1945-2016 was initiated by Sysmex Corporation on Dec 18, 2014 and is designated Class II. Reason for recall: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. The recall status is terminated (terminated Jul 25, 2016). Affected quantity: 1,137 units (US) 54 units (Canada) 9 inventory.

Recall Details

Product Type: Devices
Report Date: Jun 22, 2016
Initiation Date: Dec 18, 2014
Termination Date: Jul 25, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,137 units (US) 54 units (Canada) 9 inventory

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.

Reason for Recall

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

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.

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.