Ortho-Clinical recalls VITROS 3600 systems with software version 3.8.0 due to potential delays in critical test results. Affected units may require manual system updates to prevent treatment delays.
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 3600 immunodiagnostic systems with software version 3.8.0 because software issues can cause screen freezes and printer disconnections, potentially delaying critical test results. This delay could affect urgent patient treatments if the system shuts down during a STAT test.
The software version 3.8.0 has issues causing the system to freeze or disconnect from printers during testing. This can lead to system shutdowns to fix problems, delaying test results. If a critical test is running, this delay might prevent timely treatment for patients.
Healthcare facilities using the VITROS 3600 system with software version 3.8.0 are affected. Patients requiring urgent tests could be impacted if the system experiences delays during critical procedures.
Check for the product code 6802783 or 6802914 with software version 3.8.0. Affected units have specific serial numbers listed in the recall notice.
Verify the software version on your VITROS 3600 system. If it shows 3.8.0, it is affected.
Reach out to Ortho-Clinical for manual system updates to resolve the software issues.
Software version 3.8.0 can cause screen freezes and printer disconnections, leading to system shutdowns that delay critical test results.
No, but you should check the software version and contact Ortho-Clinical for manual updates to prevent delays in critical tests.
Verify your software version and contact Ortho-Clinical for a manual system update to fix the issues.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0543-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0543-2024 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.
