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ORTHO VISION Analyzer (2015-12-10)
- Starting date:
- December 10, 2015
- Posting date:
- January 18, 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-56674
Affected Products
A. ORTHO VISION Analyzer
Reason
Ortho Clinical Diagnostics (Ortho) has identified that under specific circumstances, the saline supply on the Ortho vision analyzer may be insufficient to process tests, without operator knowledge.
If an operator opens the liquid access door for any reason, the system software automatically resets, assuming the saline container was refilled to the maximum volume of 4700 ml, regardless of whether the operator refills the saline container or not. If an operator opens the liquid access door and does not refill the saline container to 4700 ml, the system loses track of the actual onboard saline volume. Therefore, the system can no longer accurately determine low saline volume levels and alert the operator.
Affected products
A. 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
New Jersey
UNITED STATES