Ortho Clinical Diagnostics Recalls VITROS 5600 Integrated System Analyzers
Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated 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, and the source text does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Ortho Clinical Diagnostics is recalling 2,531 units of the VITROS 5600 Integrated System, a clinical chemistry analyzer. The recall is due to a software anomaly that may result in unsuccessful calibration. The affected software version is 3.3.2 or above.
The product was distributed worldwide, including the United States (nationwide including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines. The product code is 6802413 and the UDI is 10758750002740.
This recall is classified as Class II by the FDA. Users should contact Ortho Clinical Diagnostics for further instructions on how to address the software anomaly.
The recalled product
- Product
- VITROS 5600 Integrated System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 2,531
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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