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.
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 3/5 (High).
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.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ortho-Clinical Diagnostics, Inc. 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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