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Ortho Vision Analyzer
- Starting date:
- November 23, 2016
- Posting date:
- December 13, 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-61410
Reason
Ortho Clinical Diagnostics (Ortho) has initiated a recall because Ortho confirmed that if incubation time parameters are changed when creating a user defined protocol (UDP) test, then the incubation time of the Ortho test template and other UDP tests created from the same test template may change. The system will update the incubation time with the latest selection for all UDPs that use the same template, and will also update the Ortho test template.
Affected products
Ortho Vision Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6904577
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
1001 US HWY 202
Raritan
08869
UNITED STATES