Z-2034-2017Class II

Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku...

Name: Z-2034-2017 Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku...
Creator: Sysmex America Inc
Published: 2017-03-23
License: https://open.fda.gov/license/

Sysmex America, Inc. / initiated 2017-03-23 / Terminated / root cause: design

FDA source

Sysmex America Inc began a recall of Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan on 2017-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2034-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-23
Posted: 2017-04-14
Terminated: 2019-08-22
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
Product code: GKZ Counter, Differential Cell
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 3,682 units
Distribution: Nationwide, Canada
Product codes and lots: **Model: XN-10, Product Number: AP795756, Serial Numbers: 11001 29656, 29668-29786, 29788-29798, 29800-29801, 29803, 29804, 29807, 29812, 29816-29867 **Model: XN-11, Product Number: CS297931, Serial Numbers: A1001-A1124, A1127, A1130, A1135-A1140, A1142-A1144, A1146-A1149, A1151, A1153-A1159, A1161, A1163, A1171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2034-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2034-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-10	2017-05-04

Product code GKZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)