VITROS Diagnostic System Software Defect May Cause Erroneous Patient Results
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.
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 medical device recall involving a software defect that creates risk of erroneous patient test results. No illnesses or injuries have been reported, and the hazard remains theoretical. Per the severity rubric, risk-of-harm products without reported injury warrant a High severity score.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS XT 7600 Integrated Systems (catalog number 6844461) running software versions 3.8.0 or 3.8.1. The recall affects 142 units in the United States and 78 units distributed internationally to 19 countries.
A software defect in these versions causes configurable Westgard quality control rules to fail to be properly flagged or reported when new controls are defined. When quality control statistical criteria are not met, the system does not alert users. This may result in acceptance of quality control results that should have been rejected, potentially leading to erroneous patient test results being reported.
Healthcare facilities using affected VITROS XT 7600 systems should contact Ortho-Clinical Diagnostics for information about this defect and available remediation options.
The recalled product
- Product
- VITROS XT 7600 Integrated System, Catalog No. 6844461
- 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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