Medical Device Software Defect May Cause Erroneous Lab Results
A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.
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 a Class II medical device recall affecting a laboratory diagnostic system. While no patient injuries have been reported, the defect creates a risk of erroneous test results that could lead to patient harm if unresolved. The hazard is theoretical rather than confirmed, aligning with the High severity level per the rubric.
Plain-English summary
The VITROS 3600 Immunodiagnostic System is a laboratory diagnostic device manufactured by Ortho-Clinical Diagnostics, Inc., used for immunoassays in clinical settings. This recall affects systems running software versions 3.8.0 or 3.8.1.
A software defect in these versions prevents Configurable Westgard Rules—quality control checks that verify test accuracy—from reporting as expected when a new control is defined. When these rules are selected, they fail to flag or report failures even when statistical criteria are not met, potentially allowing invalid quality control results to be accepted.
As a result, erroneous patient results may be reported to healthcare providers. A total of 75 systems are affected: 9 in the United States and 66 internationally distributed worldwide.
Healthcare facilities currently using these systems should verify whether their equipment is running software versions 3.8.0 or 3.8.1.
The recalled product
- Product
- VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
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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