Ortho-Clinical VITROS White Correction Factor Slides Recalled for Labeling Error
Ortho-Clinical Diagnostics is recalling VITROS White Correction Factor Slides because an incorrect assay value was printed on the carton, which may delay reporting of specific test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error that causes delays in reporting results rather than direct physical harm or misdiagnosis, fitting the criteria for moderate severity involving minor labeling errors.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 64 units of VITROS Chemistry Products White Reference Slides, specifically the White Correction Factor Slide (WCF), Part Number J02315. The recall affects Lot 9052-0045-6358, which has an expiry date of August 1, 2015. The product was distributed worldwide, including the United States, Puerto Rico, and various international locations.
The recall was initiated because an incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength filter. The correct assay value is 0.8658. This labeling error may cause a delay in the ability to obtain and report results for TBIL, Bu, Bc, and derived tests. The WCF slide is a tool used for reflectometer correction factor adjustment to optimize optical calibration on VITROS Chemistry Systems.
No illnesses or injuries have been reported in connection with this recall. Healthcare facilities and users of the affected VITROS systems should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions or replacement.
The recalled product
- Product
- 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
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 9052-0045-6358
- expiry date 01 Aug 2015
Distribution
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