Sysmex XN Series Hematology Analyzers Recalled for Fire Risk

Plain-English summary

Sysmex America Inc is recalling 3,682 units of the Automated Hematology Analyzer XN Series, specifically models XN-10 and XN-11. The recall is due to customer complaints that the analyzers caught fire. The fire risk is caused by the misalignment of an internal protective sheet that is designed to shield electronic components from salty reagents.

When the protective sheet is misaligned, salt deposits can build up on unprotected electronic components. These deposits may combust due to the heat generated by the electronics when the instrument cycles. A completed corrective and preventive action (CAPA) identified the root cause as a supplier providing a defective sensor ready valve and the misalignment of the electronic protective shield during manufacturing.

The affected units were distributed nationwide in the United States and in Canada. Users of these devices should contact Sysmex America Inc for instructions on how to address the defect and prevent potential fire hazards.

The recalled product

Product

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

Manufacturer

Sysmex America Inc

Category

Medical Device — Laboratory Equipment

Hazard

• fire

Affected units

3,682

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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