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Sysmex Blood Coagulation Analyzer CS-2000I et 5100 (2014-03-14)
- Starting date:
- March 14, 2014
- Posting date:
- May 5, 2014
- 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-39307
Recalled Products
A. Sysmex Blood Coagulation Analyzer CS-2000I
B. Sysmex Blood Coagulation Analyzer CS-5100
Reason
There is an issue with an irregular curve that has not been flagged accordingly there is an issue with an irregular curve that has not been flagged accordingly. This could lead under certain circumstances to an erroneously increased resy. This could lead under certain circumstances to an erroneously increased result with a Factor VIII chromogenic assay.
Affected products
A. Sysmex Blood Coagulation Analyzer CS-2000I
Lot or serial number
All lots
Model or catalog number
CS-2000I
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku, Kobe, Hyogo-ken
651-0073
JAPAN
B. Sysmex Blood Coagulation Analyzer CS-5100
Lot or serial number
All lots
Model or catalog number
CS-5100
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku, Kobe, Hyogo-ken
651-0073
JAPAN