Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24010
Brand Name:Instrument: XN-10 / 20
Model:XN-10 Serial numbers between 35612 ¡V 36264 and XN-20 Serial numbers: 14090 - 14151
Affected:
Software version:
Recalling Organisation:Cenexi SAS
52 rue Marcel et Jacques Gaucher
Fontenay-sous-Bois 94120
France
Contact Information:
Manufacturer:Sysmex Corporation
Issue:The manufacturer has identified that some XN instruments have incomplete manufacturing of the wiring cord for the FCM detector block. If the cord is moved or touched it may result in a shift to the right of the WDF scattergram which will impact on flagging of the WBC differential parameters.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:18/12/2018
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