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Sysmex XE Analyzers (2016-03-30)
- Starting date:
- March 30, 2016
- Posting date:
- April 22, 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-58058
Affected Products
A. ANALYSEUR SYSMEX XE-2100D
B. ANALYSEUR SYSMEX XE-2100L
C. ANALYSEUR SYSMEX XE-5000
D. ANALYSEUR SYSMEX XE-2100
Reason
Some packages of the replacement part, piercer set #1 (part # 971-0583-5), used on Xe-Series analyzers have an incorrect piercer inside the box.
The piercer set #1 is a consumable that is periodically replaced by the operator after a number of cycles on the Xe-Series automated hematology analyzers. A small number of boxes labeled as containing a piercer set #1 contain the incorrect piercer that is used on another Sysmex analyzer model.
Affected products
A. ANALYSEUR SYSMEX XE-2100D
Lot or serial number
Not applicable
Model or catalog number
XE-2100D
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN
B. ANALYSEUR SYSMEX XE-2100L
Lot or serial number
Not applicable
Model or catalog number
XE-2100L
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN
C. ANALYSEUR SYSMEX XE-5000
Lot or serial number
Not applicable
Model or catalog number
XE-5000
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN
D. ANALYSEUR SYSMEX XE-2100
Lot or serial number
Not applicable
Model or catalog number
XE-2100
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
JAPAN