Ortho VITROS 5600 Analyzer Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho Clinical Diagnostics is recalling 89 units of the VITROS 5600 Integrated System, a clinical chemistry analyzer, due to a software anomaly. The issue affects software version 3.3.2 or above and may result in unsuccessful calibrations. The affected units were distributed worldwide, including the United States (including Puerto Rico), Brazil, Canada, Chile, France, India, and the Philippines.
The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses, injuries, or deaths associated with this defect. The primary risk is related to the potential for the device to fail calibration, which could impact the accuracy of clinical chemistry testing.
Healthcare facilities and users of the VITROS 5600 Integrated System should contact Ortho Clinical Diagnostics for further instructions on how to address the software anomaly and ensure proper device operation.
The recalled product
- Product
- VITROS 5600 Integrated System, clinical chemistry analyzer
- Manufacturer
- Ortho Clinical Diagnostics
- Affected units
- 89
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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