Moderate FDA (Devices)·Z-2181-2019·Announced 2019-08-14

Ortho VITROS 4600 Chemistry System Recalled for Software Calibration Anomaly

Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide 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 hospitalizations, injuries, or illnesses. The hazard is a software anomaly affecting calibration, which is a functional defect rather than a direct physical or biological hazard to patients.

Plain-English summary

Ortho Clinical Diagnostics is recalling 825 units of the VITROS 4600 Chemistry System, a clinical chemistry analyzer. The recall is due to a software anomaly that may result in unsuccessful calibrations. The affected software version is 3.3.2 or above.

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 6802445 and the UDI is 10758750012343.

Healthcare facilities and users should contact Ortho Clinical Diagnostics for instructions on how to address the software issue. The source text does not specify a particular action for end consumers, as this is a professional medical device.

The recalled product

Product: VITROS 4600 Chemistry System, clinical chemistry analyzer
Manufacturer: Ortho Clinical Diagnostics
Category: Medical Device — Clinical Chemistry Analyzer
Hazard: software-anomaly
calibration-failure
Affected units: 825

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 12 products in this recall →

Same manufacturer · Ortho Clinical Diagnostics

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Same hazard · software anomaly