Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
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: FDA Class II recall affecting a critical diagnostic device without reported patient illnesses or injuries. The software malfunction creates risk of delayed patient test results, particularly for urgent cases, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 216 VITROS XT 7600 Integrated Systems with Product Code 6844461 running Software Version 3.8.0. The systems experience unresponsive subsystems, screen freezes, and printer disconnections that require shutdown and system recovery.
When the software issues occur, the system cannot process test requests properly and requires manual restart, delaying the reporting of laboratory test results. These delays directly impact patient care, particularly for time-critical or STAT (urgent) tests that require immediate diagnosis and treatment decisions.
The affected units were distributed nationwide in the United States and globally. Because of how Software Version 3.8.0 was released, affected customers could not remotely update their systems; field engineers had to manually install the update on each device.
Affected healthcare laboratories should contact Ortho-Clinical Diagnostics for technical support, information on available software updates, and guidance on minimizing delays in test result reporting while awaiting fixes.
The recalled product
- Product
- VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 216
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 (2)
- Product Code: 6844461
- UDI-DI: 10758750031610
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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