Recall Z-2034-2017— Sysmex America Inc

Name: FDA recall Z-2034-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-23

Class II · Terminated

Class II FDA medical device recall by Sysmex America Inc, initiated 2017-03-23, terminated 2019-08-22. It names 2 FDA 510(k) clearances: K141681, K112605. Product: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan. Reason: Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device..

Recalling firm: Sysmex America Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Terminated: 2019-08-22
Firm location: Lincolnshire, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K141681 — SYSMEX XN SERIESSysmex America, Inc.·cleared 2014-12-05
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

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan

Reason for recall

Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.

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