Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
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 medical device with documented risk-of-harm to patients through delayed reporting of critical test results during time-sensitive assays. No illnesses, injuries, or hospitalizations have been reported; the hazard remains theoretical.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling 51 units of its VITROS XT 3400 Chemistry System (Product Code 6844458, running Software Version 3.8.0) distributed nationwide and globally.
The recalled systems experience software malfunctions that cause unresponsive subsystems, frozen user interface displays, and printer disconnections. When these issues occur, the system must be shut down and restarted to restore function, which delays the reporting of patient test results.
These delays are concerning because they can affect the timeliness of critical and STAT (immediately urgent) assays, potentially resulting in delays to patient treatment decisions. The manufacturer determined that affected users could not install the software update themselves; a field engineer had to manually update each affected system.
Healthcare facilities currently using the affected serial numbers should contact Ortho-Clinical Diagnostics for instructions on obtaining the software fix and resuming normal operations.
The recalled product
- Product
- VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Affected units
- 51
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: 6844458
- UDI-DI: 10758750031986
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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