XN-10 & XN-11 Modules (2020-02-20)
- Starting date:
- March 13, 2020
- Posting date:
- March 13, 2020
- 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-72563
Last updated: 2020-03-13
Affected Products
- XN-10 Module
- XN-11 Module
Reason
When the result database reaches 100,000 samples, the system may unexpectedly stop and generate an error message. Only software version 22.04-10 Is affected.
Affected products
A. XN-10 Module
Lot or serial number
More than 10 numbers, contact manufacturer.
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
More than 10 numbers, contact manufacturer.
Model or catalog number
XN-11
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN