Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling nine VITROS 4600 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 illnesses, injuries, or hospitalizations. The hazard is a functional software defect (unsuccessful calibration) rather than a direct physical or biological threat, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems, which are clinical chemistry analyzers. The recall is due to a software anomaly that may result in unsuccessful calibration of the devices.
The affected units are distributed worldwide, including in the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The recall applies to units with product code 6900440, UDI 10758750033201, and software version 3.3.2 or above.
Healthcare facilities should contact Ortho Clinical Diagnostics for instructions on how to address the software issue and ensure proper device calibration.
The recalled product
- Product
- VITROS 4600 Chemistry System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 9
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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