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XN-10 and XN-11 Module
- Starting date:
- February 7, 2017
- Posting date:
- February 27, 2017
- 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-62390
Affected Products
- XN-10 Module
- XN-11 Module
Reason
Customer complaints identified two software vulnerabilities when using XN-Series Software Version 00-16 through version 00-19. One software issue impacts all XN-Series Analyzer Configurations, the other occurs only with the XN-9000 configuration that consists of multiple XN-Series Analyzers on an automation line. A device correction is required for the XN-Series Hematology Analyzers. This correction provides countermeasures to prevent incorrect demographic information, and incorrect data transmission to the laboratory information system (LIS). The correction was initiated on Monday, February 7, 2017 in Canada.
Affected products
A. XN-10 Module
Lot or serial number
Serial numbers 11205 to 28242
Model or catalog number
XN-10
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
B. XN-11 Module
Lot or serial number
Serial numbers A1006 to A1060
Model or catalog number
XN-11
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN