VITROS XT7600 System Aspiration Risk During Sample Processing
Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.
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 medical device recall involving potential aspiration of sample containers during processing, which may lead to erroneous test results. No illnesses or injuries are reported in the source material, and the hazard is described as potential rather than confirmed, placing this in the High severity category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS XT7600 Integrated System, a clinical diagnostic testing device used in laboratory settings. The recall affects 1,720 units distributed worldwide, including 834 units in the United States and 886 units internationally. The affected serial numbers range from J76000109 through J76001913 (inclusive).
During sampling center processing, there is a potential for aspiration of an unintended sample container. This condition may result in erroneous test results, compromising the reliability of clinical diagnostic information.
The product is distributed to healthcare facilities and diagnostic laboratories internationally, including throughout the United States, Canada, Australia, Brazil, Japan, and other countries worldwide.
The recalled product
- Product
- VITROS XT7600 Integrated System
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Code Information: UDI/DI: 10758750031610
- Serial Numbers: J76000109 through J76001913 (inclusive).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 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 CHE slides can cause quality control drift with performance verifiers
FDA (Devices) · 2025-07-23
- HighVITROS Performance Verifier II lots can cause quality control drift
FDA (Devices) · 2025-07-23
Same hazard · aspiration
See all →- SevereCardinal Health Recalls Presource Packs with Medtronic Microstream Components
FDA (Devices) · 2026-10-14
- SevereGiven Imaging Recalls Bravo CF Capsule Delivery Devices Due to Attachment Failure
FDA (Devices) · 2026-09-16
- High
- SevereShiley Adult Tracheostomy Tubes Recalled Due to Flange Disconnection Risk
FDA (Devices) · 2025-04-02
- HighMicrostream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
FDA (Devices) · 2025-03-26
Similar recalls
- SevereOrtho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors
FDA (Devices) · 2019-05-29
- HighOrtho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Software Error
FDA (Devices) · 2019-05-01
- HighOrtho-Clinical VITROS 5600 System Recalled for Sample Dispensing Defect
FDA (Devices) · 2018-10-17
- HighVITROS Diagnostic System Software Defect May Cause Erroneous Patient Results
FDA (Devices) · 2024-03-13
- HighOrtho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
FDA (Devices) · 2018-10-17
- HighOrtho VITROS 5600 System Recalled for Software Timing Anomaly
FDA (Devices) · 2016-06-15