Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073
FDA device recall Z-2034-2017 · posted 2017-04-14 · Terminated
Recall details
- Recalling firm
- Sysmex America Inc
- 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.
- Action taken
- Sysmex sent an Field Correction letter dated April 2017. Product will not be returned, but corrected at the customer site. The correction requires a service visit that will be documented in the Sysmex service Customer Relationship Management (CRM) software. The service report is accepted by the customer at the time of service. Completion of the service records will be tracked by reports generated from the Service CRM. For further Technical Assistance or questions please call (1 888) 879-7639.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 3,682 units
- Distribution
- Nationwide, Canada
- Date initiated
- 2017-03-23
- Date posted
- 2017-04-14
- Date terminated
- 2019-08-22
- Location
- Lincolnshire, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSMEX XN SERIES (K141681) | Sysmex America, Inc. | 2014-12-05 |
| SYSMEX XN-SERIES (K112605) | Sysmex America, Inc. | 2012-10-19 |