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Vitros Chemistry Products System-CRP Slides
- Starting date:
- November 2, 2016
- Posting date:
- November 25, 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-61206
Reason
Ortho's investigation confirmed that samples diluted (3x recommended dilution or higher) using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3 or a low c-reactive protein (CRP) concentration sample had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result.
Affected products
Vitros Chemistry Products System-CRP Slides
Lot or serial number
More than 10 lots, contact manufacturer.
Model or catalog number
- 192 6740
- 809 7990
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES