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Vitros 5,1 Fs Chemistry Products Calibrator 1
- Starting date:
- January 6, 2017
- 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-62046
Reason
Ortho Clinical Diagnostics determined that calibrator values (data/calibration mathematics) for VITROS FS Calibrator 1, Lot 91461 are not available for selection on the assay data diskettes DRVs 5904 through 5910.
VITROS FS Calibrator 1 is used on VITROS Systems to calibrate the following assays: VITROS AMPH, ASO, BARB, BENZ, COCM, D
Affected products
Vitros 5,1 Fs Chemistry Products Calibrator 1
Lot or serial number
91461
Model or catalog number
680 1873
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES