Ortho-Clinical VITROS Black Reference Slides Recalled for Mislabeling
Ortho-Clinical Diagnostics is recalling VITROS Black Reference Slides incorrectly labeled as White Reference Slides, which may cause analyzer delays.
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 limited to operational delays in test results due to mislabeling, with no reports of direct patient injury or death.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 865 units of VITROS Black Reference Slides (Catalog # J02316) due to incorrect labeling. The product is a tool used in the reflectometer correction factor adjustment procedure for VITROS analyzers.
The recall is necessary because two lots of Black Reference Slides are incorrectly labeled as White Reference Slides. If a customer fails to notice the product name or the unexpected color of the slides and uses the Black Reference Slides as White Reference Slides, the Correction Factor test will fail. This prevents the analyzer from producing results for any assays other than sodium, potassium, and chloride. If the customer does not have White Reference Slides in reserve, they cannot run the Correction Factor test correctly, leading to a delay in results for all VITROS assays except sodium, potassium, and chloride until replacement slides are delivered.
The affected lots are 9252-0058-3361 and 9252-0058-3362. The product was distributed worldwide, including in the United States and various international countries. Customers should check their inventory for these specific lot numbers and verify the product labeling and slide color to ensure they are using the correct reference slides for their correction factor adjustments.
The recalled product
- Product
- VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
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)
- Lots: 9252-0058-3361
- 9252-0058-3362
Distribution
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