Ortho VITROS 350 Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling 30 VITROS 350 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
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. The hazard is a software anomaly causing calibration failure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.
Plain-English summary
Ortho Clinical Diagnostics is recalling 30 units of the VITROS 350 Chemistry System, a clinical chemistry analyzer. The recall is due to a software anomaly in Version 9.7 that may result in unsuccessful calibration.
The affected units were distributed worldwide, including the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The specific product code is 6802153 and the UDI is 10758750002054.
Healthcare facilities should contact Ortho Clinical Diagnostics for instructions on how to resolve the software issue. No specific instructions for individual consumers are provided as this is a professional medical device.
The recalled product
- Product
- VITROS 350 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: 6802153 UDI: 10758750002054 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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