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Omnyx Integrated Digital Pathology System VL120 Scanner IVD (2015-11-19)
- Starting date:
- November 19, 2015
- Posting date:
- January 7, 2016
- 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-56510
Affected Products
A. Omnyx Integrated Digital Pathology System VL120 Scanner IVD
Reason
During internal evaluations, Omnyx became aware that variations in immunohistochemically (IHC) stained slide images may result from slides scanned with a limited number of IDP VL120 scanners. Further investigation determined that the installed scanner may have been manufactured with an out-of-specification led assembly. There have been no reported adverse events associated with this issue.
Affected products
A. Omnyx Integrated Digital Pathology System VL120 Scanner IVD
Lot or serial number
- DSAT00103
- DSAT00104
- DSAT00105
- DSAT00111
Model or catalog number
OMN-10005072-X
Companies
- Manufacturer
-
OMNYX, LLC
1251 Waterfront Place
Pittsburgh
15222
Pennsylvania
UNITED STATES