Ortho-Clinical recalls VITROS 3600 Immunodiagnostic Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include catalog numbers 6802783 and 6802914.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Ortho-Clinical is recalling VITROS 3600 Immunodiagnostic Systems with software version 3.8.1 because a defect can cause incorrect patient test results. This affects specific catalog numbers and may lead to inaccurate medical diagnoses if the system is used without correction.
A software defect in version 3.8.1 prevents the system from updating QC baseline statistics when changed by the user. This can lead to the system reporting incorrect patient test results, which might affect medical decisions.
Healthcare facilities using the VITROS 3600 system with catalog numbers 6802783 (regular) or 6802914 (refurbished) and software version 3.8.1 are most at risk. Patients receiving tests from these systems could potentially receive inaccurate results.
Check for catalog numbers 6802783 (regular) or 6802914 (refurbished) on the VITROS 3600 system. The affected software version is 3.8.1, and serial numbers are listed in the recall notice.
Verify the software version on your VITROS 3600 system. If it is 3.8.1, it may be affected.
Reach out to Ortho-Clinical Diagnostics for guidance on next steps if your system is affected.
Software version 3.8.1 is affected.
Check for catalog numbers 6802783 (regular) or 6802914 (refurbished) on the system.
No, the recall does not require immediate stop use. Affected systems may continue to operate but require verification of software version.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1224-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1224-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
