Ortho-Clinical recalls VITROS 4600 Chemistry System 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 4600 Chemistry System software version 3.8.0 because it can cause screen freezes and printer disconnections, potentially delaying critical test results for patients needing urgent treatment.
The software update caused unresponsive subsystems and screen freezes, which require system shutdowns to fix. This delays test reporting, risking treatment delays for patients needing immediate care.
Healthcare facilities using the VITROS 4600 Chemistry System with software version 3.8.0 are most at risk, particularly those handling time-sensitive patient tests where delays could impact urgent care.
Check for product code 6802445 or 6900440 with software version 3.8.0. Affected units have specific serial numbers listed in the recall notice.
Verify the software version on your VITROS 4600 system; affected units run version 3.8.0.
Reach out to Ortho-Clinical for guidance on system updates or repairs if you have an affected unit.
The software update can cause screen freezes and printer disconnections, which may delay critical test results and impact urgent patient care.
No, but you should check the software version and contact Ortho-Clinical for guidance if you have an affected unit.
Contact Ortho-Clinical to determine if your unit needs a software update or repair.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0544-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0544-2024 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.
