FDA-Device2014-03-26Class II
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement
Ortho-Clinical Diagnostics
Hazard
An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.
Sold states
Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
Affected count
64 units worldwide
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1226-2014Don't want to check this manually?
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