Ortho Clinical Diagnostics recalls VITROS 4600 Chemistry System due to software anomaly that could lead to 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 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 3.3.2 or higher could cause the device to fail calibration. This might result in inaccurate test results if the device is used without proper calibration.
Healthcare facilities using the VITROS 4600 Chemistry System with software version 3.3.2 or higher are affected. Laboratories that perform clinical chemistry tests are most at risk.
Check if your VITROS 4600 Chemistry System has software version 3.3.2 or higher. The product code is 6802445 and UDI is 10758750012343.
Verify your device's software version to see if it is 3.3.2 or higher.
The recall is due to a software anomaly in version 3.3.2 or higher that could cause unsuccessful calibration.
Check if your VITROS 4600 Chemistry System has software version 3.3.2 or higher. The product code is 6802445 and UDI is 10758750012343.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for further instructions.
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-2181-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2181-2019 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.
