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