Ortho VITROS Vapor Adsorption Cartridges Recalled for Incorrect Packaging
Ortho-Clinical Diagnostics is recalling VITROS Vapor Adsorption Cartridges because some cartons incorrectly contain Particulate Cartridges, which may bias 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, and the hazard involves potential bias in test results due to a packaging error, which fits the criteria for moderate severity involving labeling or packaging issues without reported injuries.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Vapor Adsorption Cartridges, Catalog Number 680 0100. The recall is due to a packaging error where some cartons of the Vapor Adsorption Cartridges incorrectly contain a Particulate Cartridge (Part No. J19612) instead.
The VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may interfere with Signal Reagent used with MicroWell Assays on VITROS 3600, VITROS 5600, and VITROS ECi/ECiQ Systems. If the incorrect Particulate Cartridge is installed on the system instead of the intended Vapor Adsorption Cartridge, it may bias test results.
The recall affects 15,891 units distributed domestically and 5,237 units distributed foreign. The products were distributed worldwide, including in the United States and numerous other countries. The cartridges do not have lot numbers. Users should check their inventory for cartons of Catalog Number 680 0100 that contain Particulate Cartridges (Part No. J19612) and contact the manufacturer for instructions.
The recalled product
- Product
- Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600…
- Manufacturer
- Ortho-Clinical Diagnostics
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)
- CAT No. 680 0100
- the cartridges do not have lot numbers.
Distribution
Distributed nationwide across the United States.
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