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Vitros Chemistry Products Na+ Slides
- Starting date:
- December 21, 2016
- Posting date:
- February 1, 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-62044
Reason
Ortho Clinical Diagnostics (Ortho) identified the potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ cartridges warmed between 1.5 to 8 hours then placed on the analyzer. Ortho has determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyzer storage limit.
Affected products
Vitros Chemistry Products Na+ Slides
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
837 9034
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES