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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateOrtho-Clinical VITROS Black Reference Slides Recalled for Mislabeling
FDA (Devices) · 2021-05-05
- ModerateOrtho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
FDA (Devices) · 2018-07-11
- ModerateOrtho-Clinical VITROS Lithium Slides Recalled for Imprecision
FDA (Devices) · 2017-03-22
- HighOrtho-Clinical VITROS Calcium Slides Recalled for Biased Results
FDA (Devices) · 2016-08-03
- ModerateOrtho-Clinical VITROS Chemistry LAC Slides Recalled Due to NAC Interference
FDA (Devices) · 2016-10-26
- LowOrtho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error
FDA (Devices) · 2013-07-03