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AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60
- Starting date:
- September 16, 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-60448
Affected Products
Reason
There are sudden failures of the DI-60 Home Position sensors that cause multiple error messages and prevents operation of the system. The Home Position sensors enable the analyzer to recognize proper positioning of the slides and the camera and optics to scan and locate cells on a stained blood smear. Failure of any one of the sensors disables the analyzer.
Affected products
AUTOMATED DIGITAL CELL MORPHOLOGY ANALYZER DI-60
Lot or serial number
- 60020 to 60155
Model or catalog number
- CC286297
Companies
- Manufacturer
-
Sysmex Corporation
1-5-1 Wakinohama-kaigandori
Chuo-ku
651-0073
JAPAN