Ortho Clinical Diagnostics recalls VITROS 350 Chemistry System due to potential unsuccessful calibration from software anomaly. Affected units have specific software version 9.7.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling VITROS 35:0 Chemistry Systems that may have a software issue causing calibration failures. This could lead to inaccurate lab test results if the device is used without proper calibration.
The software anomaly in version 9.7 may cause the system to fail calibration, leading to inaccurate lab test results. This could impact the reliability of diagnostic tests if the device is used without proper calibration.
Healthcare facilities using the VITROS 350 Chemistry System with software version 9.7 are most at risk. Laboratory staff and patients relying on accurate test results are affected.
Check for the product code 6802153 and unique device identifier (UDI) 10758750002054 on the device. Affected units have software version 9.7.
Verify the software version on the VITROS 350 Chemistry System. If it is version 9.7, it is affected.
The recall is for potential calibration issues, which could lead to inaccurate test results. It does not pose an immediate risk of injury or death.
Check for product code 6802153 and UDI 10758750002054. Affected units have software version 9.7.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for guidance on next steps.
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-2177-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2177-2019 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.
