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XN-10 SERIES HEMATOLOGY ANALYZER (2016-06-24)
- Starting date:
- June 24, 2016
- Posting date:
- July 7, 2016
- 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-59256
Affected products
A. XN-10 SERIES HEMATOLOGY ANALYZER
Reason
Sysmex corporation, Japan (SCJ) discovered that some XN-Series analyzers' Reaction Chamber Heaters have a possibility of abnormal heating that can lead to wire disconnection, and a scorched or burnt odour.
Affected products
A. XN-10 SERIES HEMATOLOGY ANALYZER
Lot or serial number
serial numbers 17371 - 17784
Model or catalog number
XN-10
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN