Ortho VITROS 3600 Immunodiagnostic System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.
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 2/5 (Moderate).
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 corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System, which is used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes. The recall involves 142 domestic units and 536 foreign units distributed worldwide, including the United States, Puerto Rico, and various international markets.
The recall was initiated because internal testing identified an anomaly in VITROS System Software Version 3.0 and below. Under very specific conditions, the software may associate incorrect patient demographics with a sample identification (ID) number. The affected units have serial numbers ranging from J36000101 to J36000806.
Healthcare facilities and users of the VITROS 3600 system should contact Ortho-Clinical Diagnostics for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System --- 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. The VITROS Software is a part of the VITROS 3600, 4600, &…
- Manufacturer
- Ortho-Clinical Diagnostics
Distribution
Part of a larger recall action
This product is one of 3 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 3 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
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · data integrity
See all →- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
Similar recalls
- HighOrtho VITROS 3600 Immunodiagnostic System Recalled for Software Timing Anomaly
FDA (Devices) · 2016-06-15
- ModerateOrtho VITROS 3600 Immunodiagnostic System Recalled for Software Anomaly
FDA (Devices) · 2015-01-21
- HighOrtho-Clinical Diagnostics Recalls VITROS 3600 Immunodiagnostic System Software
FDA (Devices) · 2018-12-26
- HighOrtho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly
FDA (Devices) · 2016-01-20
- ModerateOrtho-Clinical VITROS 3600 Immunoassay System Software Recall
FDA (Devices) · 2019-05-15
- ModerateOrtho VITROS 3600 Software Recall for Parameter Reset Issue
FDA (Devices) · 2020-07-08