Reported Mar 26, 2014 · Terminated
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- 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
- Lot codes and dates
Lot 9052-0045-6358expiry date 01 Aug 2015
- Amount recalled
- 64 units worldwide
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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