Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.
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: This is an FDA Class II recall of a clinical chemistry system where a software defect may cause inaccurate patient test results. No illnesses, injuries, or hospitalizations have been reported; the hazard remains theoretical without confirmed incidents.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS XT 3400 Chemistry System (Catalog No. 6844458) when running Software Version 3.8.1. This laboratory diagnostic instrument is used in clinical settings to perform chemistry testing on patient samples.
The recall addresses a software defect in Version 3.8.1 that prevents quality control baseline statistics from updating correctly when users make changes. This defect may result in erroneous patient test results being reported.
Eleven affected systems have been identified: seven distributed across US healthcare facilities in Arizona, California, Connecticut, Florida, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Missouri, Nebraska, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Washington, Wisconsin, and West Virginia. Four additional systems are located internationally in Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, the United Kingdom, Italy, Spain, Russia, France, and Belgium.
Healthcare facilities should determine whether they operate any of the affected systems using the provided serial numbers (US: J34500180, J34500289, J34500422, J34500473, J34500622, J34500861, J34500887; Overseas: J34500515, J34500609, J34500802, J34500940) and contact Ortho-Clinical Diagnostics for remediation guidance.
The recalled product
- Product
- VITROS XT 3400 Chemistry System, Catalog No. 6844458
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- software-defect
- inaccurate-test-results
Distribution
Distributed nationwide across the United States.
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