Ortho Clinical Diagnostics recalls VITROS 4600 Chemistry System due to software anomaly potentially causing unsuccessful calibration. Affected units have software version 3.3.2 or higher.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling its VITROS 4600 Chemistry System because of a software issue that could lead to calibration failures. This means lab tests might not work correctly if the system isn't properly calibrated.
The software anomaly in version 3.3.2 or higher could cause the system to fail calibration. This might lead to inaccurate lab test results, but it does not pose a direct physical risk to users.
Lab technicians and healthcare facilities using the VITROS 4600 Chemistry System with software version 3.3.2 or higher are affected. The risk is low as it only impacts calibration accuracy, not immediate safety.
Check if your VITROS 4600 Chemistry System has software version 3.3.2 or higher. The product code is 6900440 and UDI is 10758750033201.
Verify your VITROS 4600 system's software version. If it is 3.3.2 or higher, it is affected.
No, the recall is for potential calibration issues, not a safety hazard. The system does not pose a risk of injury or death.
Check the software version. Affected units have version 3.3.2 or higher, with product code 6900440 and UDI 10758750033201.
The recall does not require immediate action. Check the software version and contact Ortho Clinical Diagnostics for guidance.
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-2182-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2182-2019 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.
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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.
