Laboratory analyzer software defect may cause erroneous patient test results
A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient 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 a Class II medical device recall involving laboratory test equipment. The software defect creates potential for patient harm through erroneous test results that could affect clinical decision-making. However, no illnesses or injuries have been reported, fitting the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling certain VITROS 4600 Chemistry Systems (Catalog Nos. 6802445 regular and 6900440 refurbished) running software version 3.8.1 due to a software defect that prevents quality control (QC) baseline statistics from updating as expected when changed by the user.
This defect may cause erroneous patient results to be reported from affected devices. Quality control baseline statistics are critical for ensuring the accuracy of laboratory test results, and failure to update them properly could lead to incorrect patient data being reported.
Four affected devices have been identified in the United States, distributed across 21 states including 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. An additional 18 devices have been distributed internationally to Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, the United Kingdom, Italy, Spain, Russia, France, and Belgium.
The recalled product
- Product
- VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
- 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 test slides recalled over calibration failures delaying patient results
FDA (Devices) · 2025-09-24
- ModerateLactate slides in 18-slide cartridges recalled over calibration failures delaying results
FDA (Devices) · 2025-09-24
- ModerateCalcium test slides recalled after calibration failures delayed patient results
FDA (Devices) · 2025-08-27
- HighVITROS Performance Verifier I lots can cause quality control drift
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