Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
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 software anomaly causing unsuccessful calibration rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32, which is used with VITROS clinical chemistry analyzers. The recall is due to a potential software anomaly that may result in unsuccessful calibration.
The affected product is identified by product code 6844508 and UDI 10758750032105. The recall includes Affected Assay Data Disks (ADD) with DRV No 6032 or above. The product was distributed worldwide, including the United States, Puerto Rico, Brazil, Canada, Chile, France, India, and the Philippines.
Users of the VITROS system should check their inventory for the affected product codes and data disk versions. If the product is found, it should be removed from use and returned to Ortho Clinical Diagnostics or the distributor.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
Distribution
Part of a larger recall action
This product is one of 12 recalled by Ortho Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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