Sysmex — Class II medical device recall Z-2034-2017
Terminated recall by Sysmex America Inc, reported 2017-05-10, distributed nationwide. Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an interna
| Recall number | Z-2034-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America Inc, Lincolnshire, IL, United States |
| Recall initiated | 2017-03-23 |
| Classified | 2017-05-04 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-08-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,682 units |
| Serial numbers | 11001, 29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867, A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171 |
| Model numbers | XN-10, XN-11 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2034-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.