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XN-10 MODULE (2016-06-23)
- Starting date:
- June 23, 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, Hospitals, Healthcare Professionals
- Identification number:
- RA-59254
Affected products
A. XN-10 MODULE
Reason
Sysmex Corporation, Japan (SCJ) determined that some XN-Series analyzers had the wiring for the feeder assembly #113 improperly routed, potentially causing contact with moving parts of the tube sampling mechanism. Contact with the piercer up/down mechanism can cause abrasion of the wire's coating and a short circuit of the tube sampling mechanism.
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
JAPAN