Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System software version 3.8.0 due to potential delays in critical test results from system freezes and disconnections.
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 Diagnostics is recalling VITROS 5600 Integrated Systems with software version 3.8.0 because this version can cause system freezes and printer disconnections, potentially delaying critical test results for patients needing immediate treatment.
The software version 3.8.0 can cause the system to freeze, disconnect from printers, or become unresponsive. These issues require system shutdowns to fix, which delays test reporting. Critical tests that need immediate results could be delayed, risking patient treatment.
Healthcare facilities using the VITROS 5600 Integrated System with software version 3.8.0 are affected. Labs handling critical tests are most at risk of delayed patient treatment.
Check for Product Code 6802413 or 6802915 with Software Version 3.8.0. Serial numbers listed in the recall include J56000116 through J56004606.
Verify your system's software version by checking the device settings or documentation.
Reach out to Ortho-Clinical Diagnostics for assistance with updating the software or resolving system issues.
The software version 3.8.0 can cause system freezes and printer disconnections, which may delay critical test results and affect patient treatment.
Check for Product Code 6802413 or 6802915 with Software Version 3.8.0. Serial numbers listed in the recall include J56000116 through J56004606.
No, but you should check your software version and contact Ortho-Clinical Diagnostics for assistance with updates or fixes.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0545-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0545-2024 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.
