Medical Diagnostic System Recall Due to Software-Related System Freezes and Delayed Results
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.
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 recall with no reported illnesses or injuries. The hazard is real—delayed diagnostic results could affect patient care, especially for urgent tests—but the risk remains theoretical since the issue was identified proactively during post-release monitoring before any patient harm was documented. Per the rubric, risk-of-harm products without reported injury score at maximum 3 (High).
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS 3600 Immunodiagnostic System (Product Code 6802783 and Refurbished Product Code 6802914) running Software Version 3.8.0. The FDA-classified Class II recall was initiated due to software issues identified during post-release monitoring that cause unresponsive subsystems, unresponsive user interface (screen freeze), and printer disconnections.
These issues result in system shutdowns required to recover the system, which delays the reporting of test results. Such delays can occur during any assay, including those marked as critical or STAT (urgent), and could lead to delays in patient treatment decisions.
Approximately 63 units of the affected systems have been distributed nationwide and globally. The affected devices are identified by specific serial numbers and UDI-DI codes provided by the manufacturer.
Users of the VITROS 3600 System should contact Ortho-Clinical Diagnostics for information about the recall and available remediation options. The software update could not be automatically installed and required manual installation by a field engineer on each affected system.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 63
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 (4)
- Product Code: 6802783
- UDI-DI: 10758750002979
- Product Code: 6802914
- UDI-DI: 10758750007103
Distribution
Distributed nationwide across the United States.
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.
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