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Vitros White Correction Factor Slides (2014-01-10)
- Starting date:
- January 10, 2014
- Posting date:
- March 18, 2014
- 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-38265
Recalled Products
Vitros White Correction Factor Slides
Reason
OCD has initiated a recall as it has determined that one lot of Vitros White Correction Factor Slides was released with an incorrect assay value for the 460 nm wavelength filter. The labeling for the Vitros White Reference Slides lot 9052-0045-6358 incorrectly indicates an assay value of 0.3785 for the 460 nm filter versus the actual assay value of 0.8658. All other assay values listed are correct. The 460 nm wavelength is only used to determine the predicted concentration when processing Vitros TBIL slides or Vitros BUBC slides.
Affected products
Vitros White Correction Factor Slides
Lot or serial number
9052-0045-6358
Model or catalog number
J02315
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES