Ortho Clinical Diagnostics recalls VITROS 5600 clinical chemistry analyzers with software version 3.3.2 or higher due to potential calibration issues. Affected units may produce inaccurate test results.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated Systems that use software version 3.3.2 or higher. This software anomaly could cause calibration failures, leading to inaccurate test results for patients.
The software anomaly in version 3.3.2 or higher may cause the system to fail calibration during use. This could result in inaccurate test results for patients, potentially affecting diagnosis and treatment decisions.
Healthcare facilities using the VITROS 5600 system with software version 3.3.2 or higher are affected. Laboratories and clinics that perform clinical chemistry tests are most at risk.
Check if your VITROS 5600 system has software version 3.3.2 or higher. The product code is 6802413 and UDI is 10758750002740.
Verify your system's software version to see if it is 3.3.2 or higher.
The software anomaly in version 3.3.2 or higher may cause calibration failures, leading to inaccurate test results.
Check your software version. If it is 3.3.2 or higher, contact Ortho Clinical Diagnostics for guidance.
The recall record does not mention a specific fix or remedy.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2179-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2179-2019 from Ortho Clinical Diagnostics. 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.
