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XN-10 and X-11 Modules (2017-04-04)
- Starting date:
- April 4, 2017
- Posting date:
- May 2, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63136
Affected Products
- XN-10 Module
- XN-11 Module
Reason
The protective plastic sheet that is intended to cover and protect electronic components inside the XN-series analyzers was not positioned correctly during manufacturing. Reagent from a leaking valve created a build-up of salt on an electronic component because of the misalignment of the protective sheet. The salt build-up created a salt bridge that allowed current to continue to flow, create heat, and eventually ignite adjacent resin parts inside the analyzer.
Affected products
A. XN-10 Module
Lot or serial number
11001 - 29656
29668 - 29786
29788-29798
29800-29801
29803
29804
29807
29812
29816-29867
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
A1001-A1124
A1127
A1130
A1135-A1140
A1142-A1144
A1146-A1149
A1151
A1153-A1159
A1161
A1163
A1171
Model or catalog number
XN-11
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN