Sysmex America Inc Recall: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corpora
Sysmex America Inc Recall: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corpora is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sysmex America Inc; Product: Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-00
| Recalling firm | Sysmex America Inc |
|---|---|
| Product | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide, Canada |
| Recall initiated | 20170323 |
| Recall number | Z-2034-2017 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
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