Ortho-Clinical Diagnostics Recalls VITROS 3600 Immunoassay Systems Due to Luminometer Malfunction
Ortho-Clinical Diagnostics is recalling 28 VITROS 3600 Immunoassay Systems 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a functional failure (inability to process assays) rather than a direct physical injury or death, fitting the Moderate severity criteria for a device malfunction without reported harm.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 28 units of the VITROS 3600 Immunoassay System, specifically refurbished units with software version 3.3.2 or below. The recall is due to a luminometer malfunction that may cause the system to be unable to process MicroWell assays.
The affected systems are those that had the luminometer replaced during a service repair. The recall covers units distributed worldwide, including the United States and 23 other countries. The product is used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
Healthcare facilities and users should stop using the affected systems and contact Ortho-Clinical Diagnostics for further instructions on how to resolve the issue.
The recalled product
- Product
- VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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
- 28
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 · malfunction
See all →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
- SevereElectric Start Pressure Washers Recalled for Carbon Monoxide Hazard
CPSC · 2026-05-14