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Sysmex Blood Coagulation Analyzer CS-2000i
- Starting date:
- May 14, 2013
- Posting date:
- June 17, 2013
- 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-34207
Recalled products
- Sysmex Blood Coagulation Analyzer CS-2000i
Reason
Single factor applications at the CS-2000i systems might show increased values if a low sample, at the lower end of the measuring range, is followed by a high sample, at the upper measuring range. The extent of carry over and the clinical impact are different depending on the factor assay
Affected products
A. Sysmex Blood Coagulation Analyzer CS-2000i
Lot or serial number
Not Applicable
Model or catalog number
- 10488584
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku, Kobe, Hyogo-ken
651-0073
JAPAN