Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System due to potential unsuccessful calibration from software anomalies in version 3.3.2 or higher. Affected units may require software updates to ensure accurate lab results.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling its VITROS 5600 Integrated System clinical chemistry analyzers because software anomalies in version 3.3.2 or higher could cause calibration failures. This means lab results might be inaccurate if the system isn't properly maintained.
The software anomaly in version 3.3.2 or higher may cause calibration failures, leading to inaccurate lab results. This could affect the reliability of medical testing if the system isn't properly maintained.
Healthcare facilities using the VITROS 5600 system with software version 3.3.2 or higher are most at risk. Lab technicians and hospital staff who rely on accurate test results are impacted.
Check if your VITROS 5600 system has software version 3.3.2 or higher. The product code is 6802915 and UDI is 10758750007110.
Verify your VITROS 5600 system's software version to see if it is 3.3.2 or higher.
No, this recall applies only to healthcare facilities using the VITROS 5600 system.
The official recall does not specify software update instructions.
The recall states that software version 3.3.2 or higher is affected, but does not provide details on remediation.
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-2180-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2180-2019 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.
