Medical device software defect may cause incorrect laboratory test results
A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory 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 medical device recall involving a software defect that may cause erroneous patient laboratory results, representing a risk of harm. No actual illnesses, injuries, or hospitalization reports are mentioned in the source text, placing it at the High threshold rather than Severe.
Plain-English summary
The VITROS XT 7600 Integrated System is a laboratory diagnostic instrument used in clinical settings. Certain units running VITROS Software Version 3.8.1 contain a software defect that prevents quality control baseline statistics from updating correctly when changed by users. This defect may result in erroneous patient laboratory test results being reported.
The recall affects 44 units in the United States and 35 units in other countries. Affected US locations include 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. International locations include Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, the United Kingdom, Italy, Spain, Russia, France, and Belgium.
Healthcare facilities operating affected systems should contact Ortho-Clinical Diagnostics for corrective instructions. Affected system serial numbers are listed in the FDA recall notice for device identification.
The recalled product
- Product
- VITROS XT 7600 Integrated System, Catalog No. 6844461
- 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Ortho-Clinical Diagnostics, Inc.
See all →- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateLactate test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS CHE slides sold in Japan can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · software defect
See all →- HighMedos Velys Robotic-Assist Station Recalled for Software Movement Issue
FDA (Devices) · 2026-09-09
- HighBaxter Novum IQ Syringe Pump Recalled for Software Infusion Issue
FDA (Devices) · 2026-09-09
- HighBaxter Novum IQ Syringe Pump Software Issue Recall
FDA (Devices) · 2026-09-09
- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02