Sysmex recalled over fire hazard

Recall date

March 23, 2017

Source

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

Official notice title

Sysmex America Inc recalls Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-007…

Recall number

Z-2034-2017

FDA classification

Class II

Brand / firm

Sysmex America Inc

Sold / distributed

Nationwide, Canada

Why it was recalled

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.

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

What was recalled

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