Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System due to software anomaly potentially causing unsuccessful calibration. Affected units have specific software version 9.7.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling its VITROS 250 Chemistry System because a software issue might cause calibration failures. This could lead to inaccurate test results if the device is used without proper calibration.
The software anomaly in version 9.7 may cause the device to fail calibration, leading to inaccurate test results. This could impact the reliability of clinical chemistry tests if the device is used without proper calibration.
Healthcare facilities using the VITROS 250 Chemistry System with software version 9.7 are most at risk. Patients relying on accurate lab results from this device could be affected.
Check for the product code 8132086 and unique device identifier 10758750004409. Affected units have software version 9.7.
Verify the software version on your VITROS 250 Chemistry System. If it is version 9.7, it is affected.
Yes, if your VITROS 250 Chemistry System has software version 9.7, it is affected by this recall.
The recall does not provide a fix; the remedy is null, meaning no action is required beyond checking the software version.
The device may produce inaccurate test results if calibration fails due to the software anomaly.
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-2174-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2174-2019 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.
