Ortho-Clinical recalls VITROS XT 7600 Integrated System with Software Version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, requiring system shutdowns to recover.
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 7600 Integrated Systems with Software Version 3.8.0 because software issues can cause screen freezes or printer disconnections. This may delay critical test results, potentially affecting urgent patient treatments.
The software version causes unresponsive subsystems and screen freezes that require system shutdowns to recover. This delay in reporting results could impact critical patient treatments where immediate test results are needed.
Healthcare facilities using the VITROS XT 7600 Integrated System with Software Version 3.8.0 are most at risk. Patients requiring urgent medical tests could be affected if results are delayed.
Check for the product code 6844461 and 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 software issue.
Software version 3.8.0 can cause screen freezes and printer disconnections, requiring system shutdowns to recover. This may delay critical test results.
Check for the product code 6844461 and software version 3.8.0. Affected units have specific serial numbers listed in the recall notice.
Verify your software version and contact Ortho-Clinical Diagnostics for guidance on 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-0547-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0547-2024 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.
