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Sysmex Blood Coagulation Analyzer CA-620 and CA-660 (2017-06-20)
- Starting date:
- June 20, 2017
- Posting date:
- July 17, 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-63966
Affected Products
A. Sysmex Blood Coagulation Analyzer CA-620
B. Sysmex Blood Coagulation Analyzer CA-660
Reason
Sysmex Corporation has informed Siemens Healthcare Diagnostics Products Gmbh about a phenomenon affecting CA Series Systems. Under rare circumstances there is a potential the system might fail to alert the operator about an individual sample ID number assigned to multiple patient measurement results when using the built-in barcode scanner. Under very rare circumstances this may lead to an incorrect diagnostic and patient treatment decision due to potential of a mismatched result for the patient.
Affected products
A. Sysmex Blood Coagulation Analyzer CA-620
Lot or serial number
All lots
Model or catalog number
10712040
CA-620
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN
B. Sysmex Blood Coagulation Analyzer CA-660
Lot or serial number
All lots
Model or catalog number
10712039
CA-660
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN