Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems 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 source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling two units of the VITROS 250 Chemistry System, a clinical chemistry analyzer. The recall is due to a software anomaly in Version 9.7 that may result in unsuccessful calibration of the device.
The affected units are identified by product code 6801759 (Refurbished) and UDI 10758750001330. The distribution pattern indicates worldwide distribution, including the US nationwide, Puerto Rico, Brazil, Canada, Chile, France, India, and the Philippines.
Healthcare facilities and users should stop using the affected software version and contact Ortho Clinical Diagnostics for further instructions on remediation or replacement.
The recalled product
- Product
- VITROS 250 Chemistry System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 2
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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