Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling 30 VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
What this means for you
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 illnesses, injuries, or hospitalizations. The hazard is a software anomaly affecting calibration, which is a functional defect rather than a direct physical or biological hazard with reported harm.
Plain-English summary
Ortho Clinical Diagnostics is recalling 30 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 calibrations.
The affected units were distributed worldwide, including the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The product code is 8132086 and the UDI is 10758750004409.
Healthcare facilities should contact Ortho Clinical Diagnostics for instructions on how to address the software issue. The source text does not specify a specific action for consumers, as this is a professional medical device.
The recalled product
- Product
- VITROS 250 Chemistry System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 30
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 (1)
- product code: 8132086 UDI: 10758750004409 Affected software : Version 9.7
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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