Ortho-Clinical recalls VITROS XT 3400 Chemistry System with software version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, risking treatment delays for patients needing urgent care.
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.
Ortho-Clinical is recalling VITROS XT 3400 Chemistry Systems with software version 3.8.0 because this version can cause screen freezes or printer disconnections. These issues might delay critical test results, potentially affecting urgent patient treatment.
The software version 3.8.0 can cause the system to freeze or disconnect from printers during testing. This may delay reporting critical test results, which could impact urgent patient treatment if the delay occurs during a time-sensitive test.
Healthcare facilities using the VITROS XT 3400 Chemistry System with software version 3.8.0 are affected. Laboratories handling time-sensitive tests are at highest risk due to potential delays in critical patient care.
Check if your VITROS XT 3400 Chemistry System has software version 3.8.0. Affected units have specific serial numbers listed in the recall notice.
Verify your system's software version by checking the device settings or documentation.
Reach out to Ortho-Clinical Diagnostics for guidance on resolving the issue or updating the software.
Software version 3.8.0 can cause screen freezes or printer disconnections, potentially delaying critical test results and affecting urgent patient care.
Check if your VITROS XT 3400 Chemistry System has software version 3.8.0, as listed in the recall notice with specific serial numbers.
Contact Ortho-Clinical Diagnostics for assistance with updating the software or resolving the issue.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0546-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0546-2024 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
