Ortho-Clinical Diagnostics Recalls VITROS XT 7600 Systems Due to Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 62 VITROS XT 7600 Integrated Systems worldwide because a luminometer malfunction may prevent the processing of MicroWell assays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, indicating a risk that is unlikely to cause serious adverse health consequences.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 62 units of the VITROS XT 7600 Integrated System, software version 3.4.1 and below. The recall affects systems with serial numbers 76000108 and above, identified by UDI 1075870031610. These devices are used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes using VITROS Immunodiagnostic Products Reagents.
The recall is being issued because a luminometer malfunction may cause an inability to process MicroWell assays on the VITROS systems. This defect may impact the ability to perform specific diagnostic tests on the affected equipment.
The affected units were distributed worldwide, including the United States (nationwide) and countries such as Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. Users of these systems should contact Ortho-Clinical Diagnostics for further instructions on how to address the malfunction.
The recalled product
- Product
- VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 62
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 (1)
- Serial Numbers: 76000108 & above UDI: 1075870031610
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Ortho-Clinical Diagnostics 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 7 products in this recall →Related recalls
Same manufacturer · Ortho-Clinical Diagnostics
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · equipment malfunction
See all →- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereHologic Selenia Dimensions Mammography Systems Loose Internal Bolts
FDA (Devices) · 2026-05-20
- SevereHalyard CATH LAB Kit Recalled for Syringe Adapter Disconnection Risk
FDA (Devices) · 2026-05-13
- SevereHalyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
FDA (Devices) · 2026-05-13