Recall Z-1945-2016— Sysmex Corporation

Name: FDA recall Z-1945-2016
Creator: U.S. Food and Drug Administration
Published: 2014-12-18

Class II · Terminated

Class II FDA medical device recall by Sysmex Corporation, initiated 2014-12-18, terminated 2016-07-25. It names one FDA 510(k) clearance: K112605. Product: 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: There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values..

Recalling firm: Sysmex Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-12-18
Terminated: 2016-07-25
Firm location: Kobe-shi, Japan

510(k) clearances named in this recall

1 on FDA's record

K112605 — SYSMEX XN-SERIESSysmex America, Inc.·cleared 2012-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.