Health product recall

Sysmex XN-10 Hematology analyzer (2018-11-12)

Starting date:
November 12, 2018
Posting date:
November 30, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68486

Affected products

Sysmex XN-10 Hematology analyzer

Reason

It was observed that there was low recovery of the fluorescent platelet (PLT-F) parameter on level 3 of XN-CHECK quality control.

Affected products

Sysmex XN-10 Hematology analyzer

Lot or serial number

35739

Model or catalog number

XN-10

Companies
Manufacturer
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN