Ortho VITROS 5,1 FS Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly that may cause unsuccessful calibrations.
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 illnesses or injuries, and the hazard is a software anomaly affecting calibration rather than a direct physical injury risk.
Plain-English summary
Ortho Clinical Diagnostics is recalling 1,051 units of the VITROS 5,1 FS Chemistry System, a clinical chemistry analyzer. The recall is due to a software anomaly that may result in unsuccessful calibrations. The affected software is version 3.1 or above.
The recalled devices were distributed worldwide, including in the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The product code is 6801375 and the UDI is 10758750001132.
Healthcare facilities should contact Ortho Clinical Diagnostics for instructions on how to address the software anomaly. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 1,051
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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